CGMP | FDAZILLA BLOG

Data Integrity Trends in 483s and Warning Letters: Part 1

Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?

By Michael de la Torre|2019-05-16T13:59:20-05:00May 16th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Form FDA 483, Medical Devices, quality assurance|

Week of May 5th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement was light this week, including a single warning letter to a drug manufacturer in France. We cover it here.

By Barbara W. Unger|2019-05-14T10:05:16-05:00May 14th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla|

February 2019 | New FDA 483s

In February of 2019, we added 167 483s to our database of 27,500+ FDA inspection documents.

By Michael de la Torre|2019-05-03T12:46:33-05:00May 3rd, 2019|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, Clinical, FDA, FDAzilla, Food, Form FDA 483, FSMA, Medical Devices, quality assurance|

January 2019 | New FDA 483s

In January of 2019, we added 222 483s to our database of 27,500+ FDA inspection documents.

By Michael de la Torre|2019-05-09T15:21:00-05:00May 3rd, 2019|Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, Clinical, FDA, FDAzilla, Food, Form FDA 483, FSMA, Medical Devices, quality assurance|

Week of April 21st, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This was a very light week for warning letters with a total of two new ones posted by FDA. One was issued to a device manufacturer and we cover it here.

By Barbara W. Unger|2019-04-30T14:57:33-05:00April 30th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla, Medical Devices|

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|2019-05-02T09:35:03-05:00April 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.