2. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. (21 CFR 211.194(a)). Our review of your laboratory records revealed that you failed to report non-conforming test results on multiple occasions in multiple parts of your operations.Surely those first three tests didn't mean anything.
Analytical TestingDuring testing of [redacted] exhibit batch [redacted] in March 2016, three consecutive identity test failures occurred. The fourth test passed and you reported this conforming result. You did not include the three failures in the data package submitted to the quality unit for review or your application submission for this product. You did not conduct an investigation into the non-conforming results. At the time of the inspection, you were unaware that your analysts had not reported the failing results to your quality unit for review.
Wednesday, June 20, 2018
Warning Letter of the Week: fourth time's the charm edition
A greeting from the Center for Drug Evaluation and Research to the chairman of the board of IDT Australia: