FDA Warning Letters - Common Violations

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Updated April 25, 2024

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Trends In FDA FY2023 Inspection-Based Warning Letters - Outsourced Pharma

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The author reports six categories of the most common violations . . .

FDA warning letters: the most common violations highlighted | Life Sciences Articles:

"Before the FDA takes enforcement action on negative inspection findings, it issues a warning letter. From an analysis of 87 such letters, we learned a lot about what the FDA is looking for and ways to keep you from receiving a letter yourself. Here is the countdown of the most common violations mentioned in FDA Warning letters."

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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 - Two Proposed Rules Released to Implement FSMA

Updated October 15, 2016

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What to Expect Now that the First Big FSMA Compliance Dates Are Here

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FDA Law Blog: On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules:

"FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."

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2012 - Top Pharma Acquisitions (AZN, BMY, GSK)

The Top Pharma Acquisitions of 2012 (AZN, BMY, GSK):

"Pharma largely backed off mergers and acquisitions this year, but there were still a couple of deals earning attention. Bristol-Myers Squibb (NYSE: BMY  ) and AstraZeneca (NYSE: AZN  ) made a significant diabetes play. GlaxoSmithKline (NYSE: GSK  ) absorbed a pipeline partner with a small stable of drugs. The deals helped these big pharma players diversify their portfolio and offset revenues lost to patent expirations."

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FDA - Food Facility Registration Renewal Deadline Extended - Guidances

Updated Mar 16, 2016

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Majority of FDA-registered food facilities now outside the U.S. - Food Safety News

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FDA Extends Food Facility Registration Renewal Deadline And Issues Guidance Documents - Food, Drugs, Healthcare and Life Sciences - United States:

"The FDA recently announced that it will defer enforcement of the deadline for the biennial food facility registration renewal from Dec. 31, 2012 until Jan. 31, 2013. The action results from the FDA's delay in opening the registration renewal process from Oct. 1 until Oct. 22, 2013. The FDA is encouraging companies to complete the process early."

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Additional FDA Guidance Documents:
These answer basic questions about the food facility registration process.

• FDA Guidance for Industry: What You Need To Know About Registration of Food Facilities - Small Entity Compliance Guide
• FDA Guidance for Industry: Questions and Answers Regarding Food Facility Registration (6th Ed.)

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