Category Archives: FDA Inspections

FDA Sent These 9 Warning Letters for Pharma Companies | July 2017

We took a snapshot of the 9 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “adulterated and misbranded drug products” to sites “failing to sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination.”

From pharmaceuticals in Italy, Tennessee, and more, here they are (starting with the most recent):
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CHINA DRUG INSPECTIONS, 2016

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

China published their annual report of drug inspections for 2016 on June 2, 2017.  The 31-page document reports on a variety of inspection types including but not limited to: pre-approval inspections, GMP certification inspections, and GMP follow-up inspections.  The report is accompanied by tables and figures.  For the most part, it is easily understood, but where discrepancies seem to appear between the various values and terminology, I’ve highlighted the uncertainty.  Some types of inspections are absent here, but the report provides specific details on the inspections and the deficiencies identified.

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FDA Sent These 5 Warning Letters for Pharma Companies | June 2017

*August 3 update: we added 2 additional warning letters that were released by the FDA after we published this post on July 12, 2017.*

We took a snapshot of the 5 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from “misbranded products” to sites “failing to investigate the unexplained discrepancy.”

From pharmaceuticals in China, Texas, and more, here they are (starting with the most recent):
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FDA Sent These 6 Warning Letters for Pharma Companies | May 2017

We took a snapshot of the 6 warning letters the FDA sent to pharmaceutical companies last month.  Drug manufacturing violations ranged from failing to establish adequate written procedures to not submitting periodic adverse drug experience reports.

From pharmaceuticals in New Jersey, China, and more, here they are (starting with the most recent):
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The FDA Re-Org Has Begun. What Does it Mean for You?

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

BACKGROUND:

The FDA began a plan to align the Office of Regulatory Affairs (ORA) into a ‘program based structure’ in 2013.  This reorganization is now being implemented. The ORA is the lead for all FDA field activities including inspections of regulated products and their manufacturers, and review of imported products.  Effective May 15, 2017, we enter the transition phase as the FDA moves to reorganize the ORA structure and function to align with the agency’s centers. The FDA provides information on each of the areas, including a ‘fact sheet’ and a ‘boundary map’ for these offices.

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