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 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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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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Related articles

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

FDA Warning Letters in 2011 Mostly Focused on Batch Failures

Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures - RAPS - News - Article View:

"An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation, reports In-Pharma Technologist.

“In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations,” of which 10% were related to the company not investigating batch failures."

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Faster Product Release Through Efficient Batch Record Review - Onsite Training Class
Root Cause Analysis for Better Investigations - Onsite Training Class

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• 2011 FDA Warning Letter Review (drughealth.blogspot.com)

FDA ‘Aghast’ at Lack of cGMP, AER Compliance by Supplement Manufacturers

• People also search for FDA GMP online training programs and courses taught by SkillsPlus International Inc.

Updated September 26, 2022

Sadly, the original link broke.

- - -  the original post follows below  - - -

FDA ‘Aghast’ at Lack of cGMP, AER Compliance by Supplement Manufacturers - RAPS - News - Article View:

"The US Food and Drug Administration’s (FDA) top dietary supplement regulator said at an industry conference meeting he is “aghast at the degree of non-compliance” when it comes to current good manufacturing practices (cGMPs) and adverse event reporting (AER) in the industry, reports Nutra Ingredients USA.

Speaking 25 April to a meeting convened by the Natural Products Association, Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, said the industry has been exhibiting a level of non-compliance he says is troubling."

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The skinny on FDA regulation of dietary supplements

Spirulina (dietary supplement) tablets are made from cyanobacteria genus Arthrospira. (Photo credit: Wikipedia)

This is a quick, concise overview that contrasts how the FDA views and regulates drugs versus dietary supplements.  The author says . . .

The skinny on FDA regulation of dietary supplements | Fox News:

"Recently I spoke with representatives from the Food and Drug Administration (FDA), and it occurred that there is some confusion about what “regulation” by the FDA means when it comes to dietary supplements.  The term “regulate” has various meanings.

In a general sense, dietary supplements fall under the purview of the FDA – where there are regulations that pertain to labeling and “claims.”  However, when it comes to the measurement of safety and effectiveness – as prescription drugs must do – it is not the same.  The FDA does not ensure potency, purity or biologic activity of the ingredients in dietary supplements.  There is no registration or clearance by the FDA before a dietary supplement goes on the market."

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What is GMP?

What is GMP?:

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

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Essentials for Pharmaceutical Manufacturers - a SkillsPlus International Inc. a cGMP training class

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FDA GMP Books - Limited Previews

Image via WikipediaI'm a big fan and user of many of Google's offerings. 

While wandering through Google Books, I ran across these limited previews of these three FDA GMP-related books. I thought you might be interested.  Although the previews are limited, there's certainly enough content that can be read for learning, and plenty to review if you're considering buying the book.

Interpretation of FDA's Quality System Regulations (QSR) With QSIT references By Medical Device School (Google books preview)

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Google books preview)

Buy the book:  The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition 

Good manufacturing practices for pharmaceuticals (Google books preview)

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