FDA Warning Letters | FDAZILLA BLOG

Week of April 7th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover two warning letters to compounding pharmacies. The FDA still has not published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a few weeks ago.

By Barbara W. Unger|2019-04-17T18:35:02-05:00April 17th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla, quality assurance|

CDER Enforcement Trends in Asia Pacific

CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?

By Michael de la Torre|2019-04-12T12:36:39-05:00April 12th, 2019|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, FDAzilla, Form FDA 483, quality assurance|

Week of March 31st, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement in terms of warning letter posting was busy this week. Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years. In addition, there were another two to drug product manufacturers and one to an in vitro diagnostics firm.

By Barbara W. Unger|2019-04-09T14:49:06-05:00April 9th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, Medical Devices, quality assurance|

Week of March 25, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover four warning letters from last week including two to pharmaceutical firms and two to compounding facilities. The FDA has not yet published the warning letter issued to Lupin Pharmaceuticals that the firm disclosed a couple weeks ago.

By Barbara W. Unger|2019-04-04T09:16:42-05:00April 4th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, quality assurance|

CDER Warning Letter Trends by Facility Type

Overall, global CDER warning letter issuance has skyrocketed. Here we review the trends over the last five years in regard to facility type.

By Michael de la Torre|2019-04-05T09:20:53-05:00April 2nd, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, quality assurance|

Week of March 18th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover four warning letters this week including one for a human drug and three to device manufacturers, two of which are manufacturers of breast implants that failed to conduct post-approval studies.

By Barbara W. Unger|2019-03-26T10:46:33-05:00March 26th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, Medical Devices, quality assurance|

Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.

By Barbara W. Unger|2019-03-19T14:40:37-05:00March 19th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, quality assurance|

Part 3: An Analysis of FDA FY2018 Drug GMP Warning Letters

Here we look at the interval between inspection and issuance of warning letters and the interval between inspection and issuance of import alerts for FY2018 drug GMP warning letters.