FDA Inspections

17 08, 2017

FDA Issued 48 Product Recalls, Import Alerts, and Consent Decrees in July 2017

By | 2017-12-01T22:04:58+00:00 August 17th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Inspections, Medical Devices, quality assurance|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

16 08, 2017

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

By | 2017-12-01T22:06:04+00:00 August 16th, 2017|Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Inspections, FDA Warning Letters, quality assurance|

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): [...]

27 07, 2017

FDA issued 39 Product Recalls, Import Alerts, and Consent Decrees in June 2017

By | 2017-11-06T03:18:15+00:00 July 27th, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Medical Devices|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

21 07, 2017

CHINA DRUG INSPECTIONS, 2016

By | 2017-11-06T01:19:57+00:00 July 21st, 2017|Biopharma / Pharma, FDA Inspections, FDAzilla, quality assurance|

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 [...]

12 07, 2017

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

By | 2017-11-06T03:19:25+00:00 July 12th, 2017|FDA, FDA Inspections, FDA Warning Letters, FDAzilla, quality assurance|

*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, [...]

21 06, 2017

FDA issued 47 Product Recalls, Import Alerts, and Consent Decrees in May 2017

By | 2017-11-06T01:19:57+00:00 June 21st, 2017|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA Consent Decree, FDA Inspections, Medical Devices|

Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month! […]

14 06, 2017

FDA Sent These 6 Warning Letters for Pharma Companies | May 2017

By | 2017-06-13T10:25:53+00:00 June 14th, 2017|FDA Inspections, FDAzilla, quality assurance|

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): […]

13 06, 2017

The FDA Re-Org Has Begun. What Does it Mean for You?

By | 2017-09-15T21:58:53+00:00 June 13th, 2017|FDA, FDA Inspections, FDAzilla, Medical Devices, quality assurance|

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 [...]

1 06, 2017

28 Unique Data Integrity Deficiencies That Aren’t Really Unique

By | 2018-02-08T14:57:33+00:00 June 1st, 2017|FDA Inspections, FDAzilla, quality assurance|

by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief We’ve all been following the health authority’s identified deficiencies in data governance and data integrity for the last few years, though this enforcement action has been ongoing for almost twenty years.  A comprehensive GMP Intelligence program follows 483s and warning letters for information on the FDA’s focus.  Particularly in [...]