FDA Warning Letters | FDAZILLA BLOG

Week of June 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.

By Barbara W. Unger|2019-06-11T09:24:07-05:00June 11th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDA-Regulated Industry, FDAzilla|

Week of May 26th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement this week saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.

By Barbara W. Unger|2019-06-04T13:19:47-05:00June 4th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Medical Devices|

Data Integrity Trends in 483s and Warning Letters: Part 3

Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.

By Michael de la Torre|2019-05-30T12:01:09-05:00May 30th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA Enforcement Trends, FDA Warning Letters, FDA-Regulated Industry, FDAzilla, Form FDA 483, Medical Devices|

Week of May 19th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week’s postings included two to drug manufacturers and three to device manufacturers. FDA cites numerous repeat observations from previous inspections.

By Barbara W. Unger|2019-05-29T13:29:08-05:00May 28th, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, Medical Devices, quality assurance|

Data Integrity Trends in 483s and Warning Letters: Part 2

Part two of this series will walk through our tagging methodologies and analysis on data integrity keyword 483 citations over the last five years.

By Michael de la Torre|2019-05-30T15:05:36-05:00May 24th, 2019|Biopharma / Pharma, Clinical, FDA, FDA Enforcement Trends, FDA Warning Letters, FDAzilla, Medical Devices|

Week of May 13th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement included five warning letters to either homeopathic or OTC firms, continuing the FDA’s focus in this area. Fundamental GMPs seem to be missing.

By Barbara W. Unger|2019-05-29T13:38:27-05:00May 23rd, 2019|Biopharma / Pharma, CGMP, Clinical, FDA, FDA Warning Letters, FDAzilla, Medical Devices, quality assurance|

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|2019-05-29T13:40:17-05:00May 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|2019-05-29T13:41:44-05:00May 14th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla|

Week of April 28th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement was light on warning letters this week: one to a device manufacturer, one to a compounding pharmacy and one to a homeopathic drug manufacturer.