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.
JUUL Labs recently received a first-of-its-kind warning letter from CTP. Learn more about the warning letter and what makes it unique.
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.
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.
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.
GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER's Office of Compliance Annual Report for CY2018.
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’.
FDA posted seven warning letters this week, among which was one to a finish pharmaceutical manufacturer. We cover that warning letter here.
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.