POSTS

Post by Barbara W. Unger | September 17, 2019

Week of September 8th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.

Post by Barbara W. Unger | September 11, 2019

CTP Issues First-of-a-Kind Warning Letter to JUUL Labs

JUUL Labs recently received a first-of-its-kind warning letter from CTP. Learn more about the warning letter and what makes it unique.

Post by Barbara W. Unger | September 4, 2019

Identification of Software Validation Shortcomings

Software is used extensively in both the drug and device industry for computerized systems in manufacture and testing activities along with being used for building management control and equipment management control. GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.

Post by Barbara W. Unger | September 3, 2019

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

This week, there were two warning letters issued to pharmaceutical firms.  But first, we address an EIR associated with AveXis and the second warning letter issued to a firm for failure to comply with the Food Foreign Supplier Verification Program.

Post by Barbara W. Unger | August 27, 2019

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

This week, there were a total of five issued warning letters: three were issued to drug manufacturers, one to a compounding pharmacy, and one to a device manufacturer.  The first one issued to Deva Holdings addresses severe penicillin cross-contamination.

Post by Barbara W. Unger | August 22, 2019

Review of the Office of Compliance CY2018 Annual Report

GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER's Office of Compliance Annual Report for CY2018.

Post by Barbara W. Unger | August 20, 2019

Week of August 11th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter, and one in the food area that is a ‘first of its kind’.

Post by Barbara W. Unger | August 13, 2019

Week of August 4th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted seven warning letters this week, among which was one to a finish pharmaceutical manufacturer.  We cover that warning letter here.

Post by Barbara W. Unger | August 9, 2019

Part 2: Analysis of CY2018 FDA Warning Letters That Cite Data Integrity Failures

The second and final part of this report will cover the actions firms can take to prevent, identify, and remediate issues as well as summarizing the trends of data integrity failures.