FDA ramps up role as safety sheriff

Updated Oct 10, 2017

The original link broke.

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ONLY IN THE WORLD-HERALD; FDA RAMPS UP ROLE AS SAFETY SHERIFF FOOD MANUFACTURERS AND FARMERS PREPARE

- -  the original post follows below  - -

FDA ramps up role as safety sheriff - Omaha.com:

"The federal Food Safety Modernization Act will result in numerous changes — some large, some small — for food manufacturers and farmers in 2012 and beyond as the Food and Drug Administration continues its slow, steady rollout of new regulations. During the new law's first year, little has changed other than sweeping educational efforts to prepare farmers and food manufacturers for ramped-up federal inspection efforts. The inspections will include more, and increasingly intense, reviews of food safety and health protocols. But for 2012 and beyond, companies are preparing for financial effects. Over the next five years, the FDA is planning to issue more than 50 new rules, add inspectors and ramp up oversight efforts to the tune of $1.4 billion."

'via Blog this'

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Happy Holidays!

Wishing all of you a safe and heartfelt holiday!

 

2012 Predictions for Global Supply Chains

Supply Chain Matters Blog 2012 Predictions for Global Supply Chains- Part One | Supply Chain Matters:

"We will kick-off this series with the full listing of our ten predictions for the upcoming year.  In upcoming postings, we will provide the detailed thoughts supporting each prediction."

'via Blog this'

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2012 Crystal Ball Predicts a More Aggressive FDA

• FDA GMP QSR cGMP Online Training - respected GMP online training programs provided by SkillsPlus International Inc.

Updated February 2, 2021

Links in the original post broke.

- - -  the original post follows below  - - -

2012 Crystal Ball Predicts a More Aggressive FDA:

"According to the FDA website, 2012 will be a year of global regulatory operation and enforcement with emphasis on medical devices, drugs, and food products. "

'via Blog this'

The article references:

The FDA Pathway to Global Product Safety and Quality

It's hard to believe 2011 is nearly over, and 2012 is around the corner.  Here's to future trends!

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FDA Crackdown on Viagra-Like Supplements

• FDA cGMP QSR GMP Training - online training courses

Updated November 12, 2020

Links broke in the original post.

You might also be interested in:  Tainted Sexual Enhancement Products - FDA.gov

- - -  original post follows below  - - -

FDA Crackdown on Viagra-Like Supplements - Video - Bloomberg:

"The discovery came during a Food and Drug Administration inspection that’s part of an expanding crackdown by the agency on the $28 billion supplement industry."

'via Blog this'

My gut sense tells me that this is just the tip of the iceberg, a problem of enforcement that the FDA will be hard pressed to wrap their arms around.

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FDA Update - HCG Diet Products Are Illegal

Consumer Updates; HCG Diet Products Are Illegal:

"The Food and Drug Administration (FDA) is advising consumers to steer clear of these "homeopathic" human chorionic gonadotropin (HCG) weight-loss products. They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores. "

'via Blog this'

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FDA Refreshes Website

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FDA-approved hangover pill

• Recommended FDA cGMP online training programs and courses by SkillsPlus International Inc.

Updated May 11, 2024

Sadly, the link is now hiding behind a paywall.

---  the original post follows below  ---

Cheers! FDA-approved hangover pill promises to take edge off holiday partying - NY Daily News:

"A new FDA-approved hangover cure has hit the market just in time for holiday party season."

'via Blog this'

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What is GMP?

What is GMP?:

"GMP means something different when in different regions of the world."

'via Blog this'

You might also be interested in:
Essentials for Pharmaceutical Manufacturers - a SkillsPlus International Inc. a cGMP training class

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Electronic Orange Book Online - It'll be a wait for the 2012 version

Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition

You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

- - - original post below - - -

Electronic Orange Book Online | The Health, Drug, Prescription, and GMP Supersite:  'via Blog this'

OK you eager beavers out there!   If history serves us, you'll have to wait until the end of Q1 2012 to see a brand new cumulative version of the Orange Book that is current through the end of 2011.

In the meantime, just navigate to the link provided above for your needs.

Happy hunting, and be patient!

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FDA Consumer Updates - Food Safety Tips for Healthy Holidays

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FDA Consumer Updates; Food Safety Tips for Healthy Holidays:

"Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill.

Typical symptoms of foodborne illness are vomiting, diarrhea, and flu-like symptoms, which can start anywhere from hours to days after contaminated food or drinks are consumed.

The symptoms usually are not long-lasting in healthy people—a few hours or a few days—and usually go away without medical treatment. But foodborne illness can be severe and even life-threatening to anyone, especially those most at risk:
- older adults
- infants and young children
- pregnant women
- people with HIV/AIDS, cancer, or any condition that weakens their immune system
- people who take medicines that suppress the immune system; for example, some medicines for rheumatoid arthritis

Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home."

'via Blog this'

FDA.gov Free Title 21 CFR Search Tool

Image via Wikipedia

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CFR - Code of Federal Regulations Title 21:   'via Blog this'

The FDA.gov website makes this free search tool available.

It helps you to search within CFR - Code of Federal Regulations Title 21 - Food and Drugs: Parts 1 to 1499

Nice little search page.

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An Alternative To The Free Online GCP Training by Quintiles

• People also need recommended FDA GMP online training courses offered by SkillsPlus International Inc.

Free Online GCP Training

Updated 4/10/2015:

The Quintiles GCP training is no longer available to the public for free.

I recently discovered a free, publicly accessible GCP training program that might be of interest to you: The Good Clinical Practice (GCP) course, offered by the National Drug Abuse Treatment Clinical Trials Network

= = =

Free Online GCP Training | Clinical Research Learning Blog:  'via Blog this'

Upon completion of the program the participant will be able to:

1. Describe the ICH Good Clinical Practice (GCP) and local regulatory guidelines for good clinical practice in the conduct of clinical trials 
2. Discuss the investigator’s responsibilities in the conduct of clinical trials at the clinical site 
3. Apply ICH and local regulations to specific research activities at the clinical site

Free is good!

Quintiles helps pharmaceutical, biotechnology and medical device companies develop and market innovative therapies. Quintiles is also a full sized CRO and has its operations over more than 40 countries world wide.  

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The Exemptee Institute
The Designated Representative Institute

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FDA withdraws approval of drug Avastin to treat breast cancer

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FDA withdraws approval of drug Avastin to treat breast cancer - latimes.com:

"Studies showed that women with advanced breast cancer taking Avastin had a higher risk of death from stroke or heart attack, and that the medication raised blood pressure and increased the risk of congestive heart failure. The risk of serious bleeding was five times higher among users of Avastin than it was for those on chemotherapy only."  'via Blog this'

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FDA CDRH Learn - CDRH Learn Spanish Language Course List

FDA CDRH Learn; CDRH Learn Course List (Spanish):    'via Blog this'

The FDA CDRH offers the following courses in Spanish:

• Overview of Regulatory Requirements: Medical Devices
 [New! 9/2]

• Quality System Regulation 21 CFR Part 820 Basic Introduction

• Export Certificates for Medical Devices

• Overview of the Premarket Notification Process - 510(k)

• Bioresearch Monitoring (BIMO)
 [New! 7/25]

• Medical Device Reporting

According to Wikipedia's Languages of the United States, approximately 10% of the US population speaks Spanish.

Hope you find these free FDA resources helpful.

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FDA Inspection Classification Database Search - Free

• FDA cGMP QSR GMP Online Training - respected cGMP online training classes offered by SkillsPlus International Inc.

FDA Inspection Classification Database Search:   'via Blog this'

Wow! The FDA is disclosing inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public with a rationale for the Agency’s enforcement actions and will also help to inform public and industry decision-making, allowing them to make more informed marketplace choices and help to encourage compliance.

In this inspections database, the FDA is specifically disclosing the final inspection classification for inspections conducted of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.

Have a go at it!

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Seven Strategies for Avoiding a 483

Updated January 18, 2017

The link in the original post broke.

You might also be interested in:
In-Person Ways to Avoid Form 483 Observations and Warning Letters - MDDI

- -  original post follows below  - -

Seven Strategies for Avoiding a 483:  'via Blog this'

"What a 483 is — and isn’t. After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit."

A nice, quick and easy primer on 483s.

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Fatty Foods Addictive as Cocaine

Updated May 14, 2017

The original article is no longer accessible for free.  You can get a brief overview of the article mentioned below, from this post:  Studies Show Junk Food as Addictive as Cocaine

- -  original post follows below  - -


Fatty Foods Addictive as Cocaine in Growing Body of Science - Businessweek:  'via Blog this'

“The data is so overwhelming the field has to accept it,” said Nora Volkow, director of the National Institute on Drug Abuse. “We are finding tremendous overlap between drugs in the brain and food in the brain.”

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FDA Approves New Device - Screens for Melanoma

• Trusted FDA CGMP online training courses and programs by SkillsPlus International Inc.

Image via WikipediaUpdated 9/6/2013:

The original link broke.

You can still read about the same topic here:

New device uses light to screen for melanoma - NBC News

- - - - -

The Associated Press: New device uses light to screen for melanoma:    'via Blog this'

"The Food and Drug Administration (FDA) approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits."

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4 Health Behaviors 4 Longer Life - some alcohol

Updated July 13, 2023

Some links broke in the original post.

You can learn more here:

CDC Library - CDC.gov

---  the original post follows below  ---

CDC Features - Four Specific Health Behaviors Contribute to a Longer Life: 'via Blog this'

To live healthier and longer, drink "some."  The key is "Drink alcohol in moderation (men should have no more than two drinks per day; and women no more than one drink per day)."

For more information:

• Low-Risk Lifestyle Behaviors and All-Cause Mortality: Findings From the National Health and Nutrition Examination Survey III Mortality Study (abstract)
• CDC report finds people live longer if they practice one or more healthy lifestyle behaviors
• CDC Finds Moderate Wine Consumption Is Healthy Federal health study recommends a healthy diet, exercise, not smoking and a daily glass

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Nizoral Shampoo Available Again - I'm thrilled!

Woo-hoo!  After a very long wait, Nizoral Shampoo is back on store shelves.

The manufacturer has been is blaming a switch in manufacturing facilities.

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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FDA Awards Two New Regulatory Research Centers

Image via WikipediaFDA launches two centers to improve approval of drugs, devices - The Hill's Healthwatch:  'via Blog this'

"The Food and Drug Administration (FDA) on Wednesday awarded $2 million to support the creation of research centers tasked with improving the way new medicines and medical devices are reviewed and evaluated."

The centers will be established at the University of Maryland and Georgetown University.

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FDA Awards University Consortium To Improve Drug Manufacturing

Drug shortages: University of Maryland, other universities work to improve drug manufacturing process - baltimoresun.com:   'via Blog this'

The Food and Drug Administration (FDA) has given "a $35 million grant to" the National Institute for Pharmaceutical Technology and Education, a group of 11 universities, "to make the nation's drugs safer and less costly, and even produce more jobs, by improving the science of manufacturing."

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Our most popular course

Put fun back into GMP training!

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Should Mobile Medical Apps Require FDA Approval?

• Purchase now! FDA CGMP online training programs provided by SkillsPlus International Inc.

Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

---  the original post follows below  ---

Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: 

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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OK Folks, Get Walking! Huge Health Benefits

Kaiser Permanente leader touts the myriad benefits of walking.



So what are you waiting for?!

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FDA approves Cialis to treat benign prostatic hyperplasia

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Updated April 16, 2017:

The original link broke. You might also be interested in:
Tadalafil (Cialis) - (on MedlinePlus), and

FDA Approves Cialis to Treat Enlarged Prostate - WebMD

- -  original post follows below  - -

Image via WikipediaPress Announcements; FDA approves Cialis to treat benign prostatic hyperplasia:   'via Blog this'

'nuff said.

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Surviving FDA Enforcement Actions - Free Tips

Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:

"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."

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FDA Notes Primatene Mist Departure

Medical News: FDA Notes Primatene Mist Market Departure - in Product Alert, OTC from MedPage Today:     'via Blog this'

The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs).

Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. 

Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma.

If you're a Primatene Mist user, the FDA recommends that you see a health care professional soon to get another medicine. A doctor, physician assistant, or nurse practitioner can all help you determine the best treatment option for you. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.

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Securing Pharma Supply Chain - Senate HELP Committee Hearing - Videos

• For people who need FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

Updated November 7, 2021

A broken link was removed.

---  the original post follows below  ---

The Senate Health, Education, Labor and Pensions (HELP) Committee is examining the globalization of the pharmaceutical drug market and supply chain. Senators are seeking solutions for how to improve the FDA's inspection of foreign drugmakers and secure the drug supply chain - without adding too much to the agency's bottom line.

Here's a brief video snippet of the entire hearing. Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee:

You can watch the entire hearing, Senate Committee on Health, Education, Labor and Pensions - Full Committee Hearing - Securing the Pharmaceutical Supply Chain - September 14, 2011 (video).  If you follow this link, you can access the text of the testimony given by each witness.  If you want a slightly larger video image, you can try watching:  C-SPAN - Committee Examines Foreign-made Pharmaceuticals - September 14, 2011 (video). 

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Make GMP Training Effective - free tips

• FDA GMP QSR cGMP Online Training - popular GMP online training classes offered by SkillsPlus International Inc.

Updated November 1, 2021

The original link broke.

You might also be interested in recommended FDA CGMP online training courses and programs by SkillsPlus International Inc.

---  the original post follows below  ---

More food for your GMP training thoughts. Some free training tips.

Why GMP Training Does Seem To Work - SkillsPlus International Inc. Training Tips (pdf):  'via Blog this'

In a nutshell:

• You must address poorly designed or delivered training.
• It is essential that you align what's preached with what's practiced.
• The organization must support and encourage GMP compliance in everything that they do.

For more information:

SkillsPlus International Inc. - Compliance training experts. GMP, QSR, Designated Representative and Exemptees.

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Courses, classes, workshops, and seminars - FDA QSR GMP cGMP training

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Will the FDA issue 10,000+ 483s in 2011?

FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog:   'via Blog this'

The number is kind of shocking!  According to the FDAzilla Blog:

"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."

According to e-How - The Definition of FDA 483:

FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.

You might also be interested in:

Inspection Detection - a GMP training game by SkillsPlus Intl Inc.

An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.

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Raise Mesothelioma Awareness - Mon 9-26

Image via Wikipedia
Updated 10/30/2015:  Here's info on the 2015 awareness day

= = = original post below = = =

Help raise awareness of mesothelioma and curemeso.org with an appearance in the Today Show's audience!,

Mesothelioma Applied Research Foundation:   'via Blog this'

Wendi Lewis reports in Meso warriors will assemble on the Plaza for Mesothelioma Awareness Day:

"The Mesothelioma Applied Research Foundation is once again issuing the call for all Meso Warriors to gather at Rockefeller Plaza in New York City on Monday, September 26, for Mesothelioma Awareness Day."

• Festivities will kick off on Sunday, Sept. 25, at 6 p.m. with a gathering at Bill’s Bar and Burger Rockefeller Center. 
• Monday, Sept. 26, Meso Warriors will meet on Rockefeller Plaza at 5:30 a.m. ET.

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GMP Audit Checklist For Drug Manufacturers

• The respected and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.
  

Updated August 2, 2024

The original link broke.

You might also like:

GMP Audit Checklist For Drug Manufacturers - ISPE.org

---  the original post follows below  ---

GMP Audit Checklist For Drug Manufacturers:  'via Blog this'

I'm always on the lookout for goodies out there.  Checkout this audit checklist.

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FDA on Tattoos and Permanent Makeup

Updated November 18, 2024

The original link broke.

---  the original post follows below  ---

FDA Webinar on Tattoos and Permanent Makeup (PDF):  'via Blog this'

The FDA hosted a webinar on tattoos and permanent makeup. Bhakti Petigara Harp, Ph.D., of the Office of Cosmetics and Colors, Division of Color Certification and Technology in FDA's Center for Food Safety and Applied Nutrition, provided an overview of the composition of tattoo and permanent makeup inks and the pigments used in them, as well as their regulatory status. Dr. Petigara Harp talked about problems that have occurred with the use of these inks, such as allergic reactions, infections, and scarring, and addressed FDA's response to these occurrences. She also discussed misrepresentation of these inks and pigments as "FDA approved." 

Background:
FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, because of other public health priorities and a previous lack of evidence of safety concerns, FDA traditionally has not exercised its regulatory authority over tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions. In addition, concerns raised by the scientific community regarding the pigments used in these inks have prompted FDA to investigate the safe use of tattoo inks. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on inks. As new information is assessed, the agency will consider whether additional actions are necessary to protect public health.
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Additional Resources:
Tattoos & Permanent Makeup: Fact Sheet - FDA.gov

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Sixth Annual FDA Inspections Summit

Updated April 3, 2017

You might also be interested in:
FDA News presents the 12th Annual FDA Inspections Summit - Nov 1-3, 2017, Doubletree Bethesda Hotel, Bethesda, MD (Washington, DC)


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Sixth Annual FDA Inspections Summit:  'via Blog this'

This caught my eye. I'm sharing it because I know that many of you have an interest in FDA inspections.  The Sixth Annual FDA Inspections Summit is scheduled for Tuesday, Oct. 4 - Thursday, Oct. 6, 2011, in Bethesda, MD.

With a quick Google search, the other large event seminar offering an FDA Inspection focus, was this seminar held earlier in the year:

ISPE - The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,”

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Drug Poisoning Increase In Children

Pharmaceutical drug poisonings rise in children - latimes.com:  'via Blog this'

The LA Times article gives a nice highlight and summary of the much longer research article published in the Journal of Pediatrics, The Growing Impact of Pediatric Pharmaceutical Poisoning.

To give you an idea of what they found,  I'm sharing just a portion of their conclusion:

"We conclude that the problem of pediatric medication poisoning is getting worse, not better. Past preventive efforts have proved to be inadequate. More children are exposed, more are seen in an ED, more are admitted, and more are injured each year."

Not surprisingly, there are mentions that medical bottles and packages may need to be redesigned to limit how fast a child can consume medication, and that drugs should be stored in locked cabinets, and unused medications need to removed from the home.

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Women - A Drink A Day Leads to Longer Life

Image via WikipediaStudy of the Day: One Drink a Day May Lead to One Long Life - Atlantic Mobile:  'via Blog this'

"Talk about toast-worthy. New research shows, for older women, one alcoholic beverage a day may help keep the doctor away."

Reference:
The full study, "Alcohol Consumption at Midlife and Successful Ageing in Women: A Prospective Cohort Analysis in the Nurses' Health Study," is published in the journal PLoS Medicine.

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The FDA on Gluten-Free Food Labeling

FDA Consumer Updates; A Glimpse at 'Gluten-Free' Food Labeling:  'via Blog this'

Whether as muffins, rolls, or loaves, wheat bread is found in most households. But few consumers may appreciate the substance that helps the dough rise, keeps the bread from falling apart, makes it chewy, and adds to its flavor.

That substance is gluten. Breads, cakes, cereals, pastas, and many other foods are made with wheat or added wheat gluten to improve their baking quality and texture.

Technically, gluten represents specific proteins that occur naturally in wheat. However, the term “gluten” is commonly used to refer to certain proteins that occur naturally not only in wheat, but also in rye, barley, and crossbreeds of these grains and that can harm people who have celiac disease. The only treatment for this disorder is a life-long gluten-free diet.


FDA Press Announcements; FDA reopens comment period on proposed ‘gluten-free’ food labeling rule:

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.

One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

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Offshore Drug Manufacturing Plants - Quality problems more likely

Image via WikipediaQuality problems more likely in offshore drug plants, study finds - FiercePharma:  'via Blog this'

"Researchers found drugs made in offshore plants are more likely to have quality problems than meds made by the same companies in the U.S. -- and that calls into question the industry's move to ship more production overseas."

According to one of the authors, John Gray, in the release from Ohio State:

"One of the managers I spoke to currently in a Puerto Rican plant said it best: No one here knows what it looks like to run a world-class operation in terms of quality control. This kind of knowledge can't just come from books and manuals, especially when you're dealing with workers who speak another language and come from another culture."

For more information:
Quality risk in offshore manufacturing: Evidence from the pharmaceutical industry (abstract)

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Disaster Supplies and Preparedness Checklist

Image via WikipediaThere have been recent global earthquakes, floods, and storms.

I live in the San Francisco Bay Area of California, and I sense that we're due for an earthquake.

To that end, I'm sharing this checklist for all of us to start following, so that we can be fully prepared for whatever disaster comes our way:

Your Family Disaster Supplies and Preparedness Calendar (pdf)

Be safe, be well!

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