‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT

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Read the full article:  ‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT

According to the article:

"Over the past decade, cocktails of drugs from opioids to antidepressants have been showing up in rivers all over the U.S. Studies have detected these chemicals in the bodies of fish and aquatic insects, altering behaviors that are key to survival. Now, an investigation by STAT and Type Investigations identifies for the first time major drug companies that are likely dumping substantial quantities of drugs from their manufacturing facilities into rivers and streams."

Catalent stops production at French plant, brings in law enforcement after it twice detects tampering - FiercePharma

Read the full article: Catalent stops production at French plant, brings in law enforcement after it twice detects tampering - FiercePharma:

"U.S.-based Catalent ($CTLT) has halted production at a softgel capsule manufacturing facility in France at the request of regulators after several incidents in which it appears someone within the plant purposely mixed the wrong capsules into batches. The company said it is working with French law enforcement and regulators to find out what happened."

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FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products - FDA Law Blog

Read the full article: FDA Law Blog: FDA Issues Final Rule on Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products:

"The final rule requires “all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the products in the United States.”"

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Federal Register | Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

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Drug Making Breaks Away From Its Old Ways - WSJ

Read the full article: Drug Making Breaks Away From Its Old Ways - WSJ:

"Under the new approach, raw materials are fed into a single, continuously running process. Many other industries adopted such a “continuous-manufacturing” approach years ago, because quality can be checked without interrupting production—with weeks shaved off production times and operating expenses cut by as much as 50%.

Until recently, pharmaceutical companies have been stuck making drugs the old-fashioned way, mixing ingredients in large vats and in separate steps, often at separate plants and with no way to check for quality until after each step is finished. Any desire to modernize was partly blunted, industry officials say, by the high margins netted on the industry’s string of billion-dollar-selling drugs."

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Dietary Supplement Manufacturer Audit Preparation - NPI

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Read the full article: Dietary Supplement Manufacturer Audit Preparation - NPI:

"Common Mistakes Auditors Find

Recent GMP audits reveal companies failure to perform tasks in two main areas:

Quality Issues

• Perform required identity testing on incoming dietary ingredients raw materials
• Set appropriate specifications for raw materials, components and finished good product
• Perform finished good product testing confirming identity, strength and composition
• Lack of finished product release criteria (does finished batch conform to product spec?)
• Adopt written procedures (e.g., SOPs)
• Prepare and follow master manufacturing records (MMR) and/or batch production records (BPRs) for manufacture of dietary supplements (with formulation and batch size)
• Document corrective actions undertaken
• To conduct required material reviews and make disposition decisions

Facility Issues

• Physical plant design
• Sanitation requirements of the physical plant and associated grounds
• Issues with manufacturing equipment and utensils"

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FDA Prohibits Drug Importation from Ranbaxy’s Plant in Mohali, India

Press Announcements > FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert:

"The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP)."

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FDA - 70% of Supplement Companies Violate Rules

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FDA official: 70% of supplement companies violate agency rules:

"About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.

Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown."

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FDA Draft Guidance Summarized: Delaying, Denying, Limiting, or Refusing a Drug Inspection

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Updated November 4, 2020

Some the links broke in the original post below.

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FDA Issues Draft Guidance on Definition of Denying, Delaying, Limiting or Refusing to Permit Inspection - The National Law Review

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA.gov (PDF)

- - -  original post follows below  - - -

Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection - FDA Lawyers Blog:

" . . . in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)"

Read the draft guidance:
FDA - Draft Guidance for Industry - Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF)

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What Should I Expect During An Inspection? - FDA Basics

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FDA Basics for Industry > What should I expect during an inspection?:

"FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem. The investigator will present credentials and "Notice of Inspection" (FDA Form 482) upon arriving at your plant. A knowledgeable person in your firm, such as the plant or production manager, preferably designated ahead of time, should accompany the investigator at all times. It is in your best interest to fully understand FDA's inspection procedures. When you are unsure of certain actions taken by the investigator, don't hesitate to ask questions." . . .

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FDA Facts About Current Good Manufacturing Practices (cGMPs)

If you're new to the FDA's cGMPs, then follow the link below, to their website. It explains what the cGMPs are all about:

Manufacturing > Facts About Current Good Manufacturing Practices (cGMPs):

"Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.  This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?" . . .

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Ben Venue Signs FDA Consent Decree Over Drug Manufacturing Problems

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Updated October 19, 2020

The link in the original post broke.

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Ben Venue Signs Consent Decree With FDA To Address Manufacturing Problems at Plant - Bloomberg Law

- - -  original post follows below  - - -

Ben Venue Signs Consent Decree with FDA Over Drug Manufacturing Problems | Fox Business:

"Ben Venue Laboratories, the contract drug manufacturer whose quality lapses caused a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil and recalls of numerous other drugs, reached an agreement with U.S. authorities governing the company's efforts to fix the problems.

Ben Venue, a Bedford, Ohio, division of Germany's Boehringer Ingelheim, signed a so-called "consent decree" with the Food and Drug Administration, according to a company statement and court documents filed by the Department of Justice in federal court in Ohio.

The consent decree bars Ben Venue from making and selling certain drugs until the company can demonstrate that it has taken certain steps to correct its manufacturing problems, among other requirements."

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Dietary Supplement Industry - Vulnerable to FDA Enforcement

Dietary Supplement Industry: Everyone Vulnerable to FDA Enforcement:

"Who is at risk in the dietary supplement industry from the enforcement arm of FDA?

The short answer, says veteran attorney Anthony Young, is everybody.

"We are no longer an unregulated industry in any way," declares Young, a partner with Kleinfeld, Kaplan and Becker, a firm concentrating on the regulation of products subject to FDA jurisdiction."

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FDA Exerts FSMA Authority - Food Safety

Updated June 24, 2024

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New Era of Smarter Food Safety - FDA.gov

---  the original post follows below  ---

FDA Writing New Chapters in Food Safety History | FDA Voice:

"With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce.

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. "

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More fake drugs now using active ingredients

SecuringIndustry.com - Many more fake drugs now using real APIs, US official says:

"The US Department of Commerce reports that more and more counterfeit pharmaceuticals are using real APIs to trick patients.

Globalisation of the active pharmaceutical ingredient (API) supply chain means raw materials are more readily available in countries where counterfeit manufacturing takes place.

The trend has helped counterfeiters change the composition of their products, Security Management reports.

"Twenty years ago most counterfeit medicines did not contain any medicinal ingredients. They had ground up dry wall, sawdust, anything to make the product look real," said Jeffrey Gren, director, Office of Health and Consumer Goods at the US Department of Commerce, said."

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Ranbaxy Generic Lipitor Recalled

Generic Lipitor Recalled - Another Sign The FDA Needs Help? - Forbes:

The Ranbaxy recall comes after a host of problems with Ranbaxy in recent years – including recalls, admissions of false testing data presented to the FDA, and other manufacturing problems. The troubles at Ranbaxy also point to the challenge a foreign drug company has when buying another drug company. Almost immediately after Daiichi Sankyo acquired a majority stake in Ranbaxy, problems sprang up.  With no expertise running an Indian generics drug company, let alone one that had been family controlled up to that point, DaiichiSankyo was blindsided by the troubles."

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FDA Asking for More Control Over Drug Compounding

F.D.A. Asking for More Control Over Drug Compounding - NYTimes.com:

"Among the changes proposed by Dr. Hamburg are requiring larger compounders to register with the F.D.A. and abide by its so-called good manufacturing practice [GMP], which requires drug producers to report any problems with their products to the agency. She is also recommending new labeling requirements that would make the origin and the risks of a compounded drug clear. She is also requesting that some products, including drugs with complex dosage forms, be banned for compounders.

“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen federal standards for nontraditional compounding,” Dr. Hamburg stated in the written testimony. “Such legislation should appropriately balance legitimate compounding that meets a genuine medical need with the reality that compounded drugs pose greater risks than those that are evaluated by F.D.A.”"

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FDA’s Top Supplement Issues

FDA’s Top Supplement Issues:

"Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, gave a quick talk this morning at SupplySide West, touching on FDA’s top regulatory concerns for supplements. He said the most important topic is good manufacturing practices (GMPs), but that’s not the only supplement issue that’s currently top of mind to FDA.

In short, Fabricant said these are the most pressing industry issues: . . ."

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• FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs (drughealth.blogspot.com)

Device Manufacturing 101: Orthopedic Implants and Instruments

Updated May 31, 2025

One of the links broke.

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Popular FDA cGMP online training classes, programs, and courses by SkillsPlus International Inc.

---  the original post follows below  ---

. . .  and don't forget about all the FDA's QSR regulations that have to be followed!

Device Manufacturing 101: Orthopedic Implants and Instruments:

". . . have you ever wondered about the steps that go into manufacturing these devices? There’s a lot of work in the process that turns an idea into an actual physical product, and often times it’s something we don’t think about.

During our recent trip to Northeast Indiana, we had the opportunity to visit a number of manufacturing sites and learn the high-tech processes and technology that go into producing orthopedic implants and instruments. Here’s how it works!"

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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."

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FDA Crackdown on Viagra-Like Supplements

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Updated November 12, 2020

Links broke in the original post.

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- - -  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."

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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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