In a missive from the Center for Drug Evaluation and Research to Mr. Prashant K. Tewari, the Managing Director of USV Private Limited, an unusual failure mode for a warning letter:
4. 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)).How do you fail identity testing of a compound? Isn't that just "do the IRs match?" Whoa.
[Redacted] failed identity testing. You accepted a passing retest result without any investigation of the failed result.
In your response, you state that you attempted to conduct a retrospective investigation of the analysis which occurred more than a year earlier, and tentatively concluded that the out-of-specification (OOS) result might have been caused by analyst error. Also, your investigation recommends replacement of the polarimeter on which the OOS result was obtained.
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looks like Blogger doesn't work with anonymous comments from Chrome browsers at the moment - works in Microsoft Edge, or from Chrome with a Blogger account - sorry! CJ 3/21/20