FDA Most Common Drug and Device 483 Items

Updated July 30, 2024

The original link broke.

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Inspection Observations - FDA.gov

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The AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 items. You'll want to read them all, and here are teasers from each category:

Drug GMP FDA-483 (observational) items:

• Responsibilities and procedures of the Quality Control unit are not in writing

The most common Medical Device GMP FDA-483 (observational) items:

• Deficiencies in complaint file system

Pharma Mergers - 2009 review - 2010 predictions

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

Continuing the thread of the pharma year in review, and what 2010 might look like. Here's a Motley Fool look at 2009 and 2010 from the perspective of pharmaceutical mergers and acquisitions, 2009: The Year Pharma Learned to Love Itself. In a nutshell:

1. 2009 ushered in a number of consolidations
2. Consolidations might not work well or scale well due to the challenges of integration
3. The author, Brian Orelli predicts for 2010, "While anything is possible, I wouldn't expect much more consolidation of major drugmakers."

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FDA Holiday Food Safety

The holidays are about spending time with friends and family. Naturally, food will be served and shared. So beware! Take a few moments to review best food handling practices to keep everybody happy and food healthy! Follow these FDA food safety recommendations, Food Safety Tips for Healthy Holidays, or download this newsletter, Food Safety Tips for Healthy Holidays (pdf). 

Bottomline...

1. Clean
2. Separate
3. Cook
4. Chill

Previous Posts: Happy Thanksgiving - Celebrate These Food Safety Tips 

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Cramer - Top 4 Healthcare Predictions for 2010

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... rather, that's Cliff Cramer. In looking for 2010 trends, and predictions, I stumbled across his predictions, Top 4 Healthcare Predictions for 2010. It's the start of an interesting and provocative discussion of his 4 predictions (which I've truncated):

1. Multi-national pharmaceutical and medical technology companies will increase their investments in emerging markets.
2. Information technology will make greater strides in a healthcare industry.
3. Healthcare reform will continue across developed and developing markets.
4. Consolidation will be a major theme in 2010.

I recommend you go to his post, and jump into the discussion. On some gut level, I'm hoping the predictions ring true as my retirement investments will benefit.

Previous Posts: Biotechnology Trends 2010 - Free Report 

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FDA Cosmetics GMP Inspection Checklist - Free

• FDA cGMP QSR GMP Training - online training courses by SkillsPlus International Inc.

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics

The FDA offers a Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetic establishment instructions, that are excerpted from the FDA's Inspection Operations Manual. The FDA checklist may serve as guidelines for effective self-inspection. According to the FDA, a good inspection score means that an establishment follows good manufacturing practice.

Previous Posts:
30 FDA GMP Compliance Tips
FDA Audit Preparation - Audit Theory - Be Ready

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 Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. 

Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF). 

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Biotechnology Trends 2010 - Free Report

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Here's the next installment of my hunt for 2010 trends, forecasts, and predictions. Pharma-Reports.com just announced the availability of its executive report, Biotechnology Trends 2010 (free). I've provided the link to the request form. The report examines the most significant trends in biotechnology and their impact on rising health care costs, the aging population, and an overall rise in the incidence of disease. The report also discusses scientific advancements in proteomics and biomarkers, molecular manufacturing, and the development of smart materials.

Previous Posts: Looking Ahead to Pharma 2010 - Through the IBM innovation lens GMP Training - The end is near - I mean 2009! IMS Predicts Pharma Growth in 2010 CDC - Brand New 2010 Yellow Book for Travelers - free - online 

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FDA New Guidance on PET Drugs GMPs

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

Updated June 24, 2024

The original link broke.

You can still read about the same topic here:

Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP)  - FDA.gov

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This FDA guidance, Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP), is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

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Say No To Drugs PSAs - Public Svc Announcements over the yrs

Updated April 21, 2017
This post didn't age well. The video links have broken, so I've removed them from the original post. You can get a sense of the video with this collection of photos:
PSAs Say No to Drugs

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I was catching up with news this wet Saturday morning and ran across this CBS News mini-history of anti-drug messaging over the years. Enjoy!

For related photos and links specific to this video clip go to CBS News PSAs Say No to Drugs Photos.

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Sugar As Addictive As Cocaine Or Heroin
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FDA - Food Defense Tool - CARVER + Shock

• FDA cGMP Online Training - recommended GMP online training courses offered by SkillsPlus International Inc.

Updated March 18, 2021

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CARVER + Shock Primer - FDA.gov

AN OVERVIEW OF THE CARVER PLUS SHOCK METHOD FOR FOOD SECTOR VULNERABILITY ASSESSMENTS

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The FDA of the U.S. Department of Health and Human Services and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) have created an online tool to help farmers and producers assess and mitigate vulnerabilities in their production processes. The risk assessment tool (free software) called Agriculture CARVER + Shock is designed to help the food industry at the farm level – implement food production security methods. CARVER + Shock is an offensive targeting prioritization tool adapted from the military version (CARVER) for use in the food industry. The tool can be used to assess the vulnerabilities within a system or infrastructure to an attack. It allows the user to think like an attacker to identify the most attractive targets for an attack. By conducting a CARVER + Shock assessment of a food production facility or process, the user can determine the most vulnerable points in their infrastructure, and focus resources on protecting the most susceptible points in their system. 

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Upton Sinclair Belated Birthday - Inspired FDA Creation 

FDA Updates Warning Letters Web Page 

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HIV AIDS - 97 US Medicines in Testing - PharmaTimes

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This is a really nice snapshot of some of the clinical testing going on in the HIV AIDS field, PhRMA's Pharmaceutical Researchers Are Testing 97 Medicines And Vaccines for HIV and Related Conditions. The article provides a quick overview for medicines grouped by:

1. Anticancer
2. Antiviral
3. Gene therapy
4. Immunomodulators
5. Vaccines
6. Other

Previous Posts: Abzymes Pinpoint The HIV Achilles Heel 109 HIV Drugs And Vaccines Under Development Listen To People With AIDS and HIV (audio)

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