New Recalls | Weeks of January 2nd & 9th, 2018

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New Recalls | Weeks of January 2nd & 9th, 2018

By |2019-05-29T14:36:02-05:00January 16th, 2019|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Inspections, FDAzilla|

It’s been a light couple of weeks due to the partial government shutdown. Here are the latest recalls.

An FDA update a day keeps the recalls away.
Get free recall, 483, & Warning Letter reports.



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About the Author

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. | | 805.217.9360

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