FDA Warning Letters

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): [...]

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, [...]

30 04, 2016

Does an FDA Import Alert automatically equate to an impending FDA Warning Letter?

By | 2018-02-14T12:10:07+00:00 April 30th, 2016|Biopharma / Pharma, CGMP, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices, MOST POPULAR|

by Barbara Unger, FDAzilla GMP Quality Expert INDIA | IMPORT ALERT 66-40 and Association with Warning Letters Regarding These Sites | Detention Without Physical Examination of Drugs from Firms Which Have Not Met Drug GMPs  […]