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

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.

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Week of September 29th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

In another first-of-a-kind set of warning letters, the FDA and DEA issued joint warning letters to four online networks which are marketing unapproved opioid medicines. Also, we include the warning letter issued to Lupin Limited which seems to show they haven’t corrected their shortcomings since the November 2017 warning letter.

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Week of September 15th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm.  The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.

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Week of September 8th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.