Barbara W. Unger

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function. Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

WWL111919

FDA Warning Letters Week of 11/10/2019: FD&C Act and Continued Sartan Enforcement

A busy week for enforcement. Included in this week of warning letters are Dollar Tree (in which FD&C Act is cited rather than CFR), Cadila Healthcare Limited, and Mylan Laboratories Limited among others.

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FDA Warning Letters Week of 11/3/2019: Lost Documentation and Data Integrity

Yet another week with a preponderance of warning letters issued by the Center for Tobacco Products. We cover one warning letter issued to an OTC manufacturer in China.

FDA Warning Letters Week of 10/27/2019: Sterility and Spores

A slow week for drug and device warning letters as FDA continues their enforcement focus on e-cigarette suppliers.  Enforcement this week includes a lone GMP warning letter to a PET drug manufacturer.

Enforcement Actions Against Sartan Manufacturers

Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years.  These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals. Here, we address some of the enforcement actions taken against a few of the notable players in this series of events.

Week of October 20th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement this week includes only two drug warning letters, one of which was issued to a PET drug manufacturer.  Firms that are bedeviled by mold findings in both surface and personnel EM would be well served to read this warning letter and the one issued to a sister site last year.

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Week of October 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Another busy week on the warning letter enforcement front. We address one warning letter to a device firm, one to a fertility clinic with similar issues to one posted last week, and four to drug firms.  This includes the warning letters to Glenmark and Torrent located in India, both of which were announced last week but not yet posted by FDA.

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Week of October 6th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

In the areas we cover, there was only one posted warning letter to a fertility clinic, but we also cover two announced warning letters that FDA has not yet published.

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Repeat Deficiencies in Lupin Limited Warning Letters

When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.