1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Your firm invalidated out-of-specification (OOS) results without adequate investigation and scientific justification. Examples include:
....In March, 2017, you obtained OOS results for the [redacted] impurity during stability testing of [redacted] injection batches [redacted]. You suspected the analyst may have incorrectly rinsed the HPLC vials. New samples prepared and tested by a second analyst using both the original column and a new column, as well as old and new vials, also yielded OOS results. Although you lacked sufficient evidence, your investigation concluded that the OOS results were due to sample vial contamination. You invalidated the OOS results after obtaining passing results from testing retain samples.Rinsing HPLC vials??!?!?
(Someone who does science in the United States probably has no idea as to the constraints around consumables in the developing world. But still!)