3. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm also failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and (b)).
Your firm distributed [redacted] lots of [redacted] and [redacted] lots of [redacted] to the U.S. supply chain without testing the identity, strength, purity, and quality of the active ingredient. Additionally, all your OTC drug products have a specification for the absence of [redacted]; however, this test was not performed during finished product testing. Furthermore, you have not established any specifications for the “[redacted]” used in all your OTC drug products, nor is any testing performed on the “[redacted].”
In your response, you provided assay testing results for products within expiry that have been distributed in the United States. However, these products have not been tested according to all your specifications, including the absence of [redacted]. Furthermore, you did not provide any established component specifications for the “[redacted]” used in all your OTC drug products.Well, here's hoping that the [redacted] did not ever make in into someone's system, otherwise the [redacted] would really hit the fan.