Seatex, LLC — FDA Warning Letter Findings

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm’s quality system was inadequate. Specifically, your firm was unable to demonstrate that your QU had the responsibility and authority to ensure critical elements of drug product manufacturing operations were adequately controlled…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm manufactured over-the-counter (OTC) hand sanitizer drug products on equipment also used to manufacture non-pharmaceutical products, including industrial chemicals such as floor cleaner. It is unacceptable as a matter of CGMP to manufacture drugs using the same equipment that you use to manufacture these non-pharmaceutical products due…

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 did not adequately investigate out-of-specification (OOS) results. Specifically, your practice to test a new sample if the original result fails, until either a third failing result or a passing result is obtained, is not scientifically…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm does not perform identity testing for incoming components, including ethanol and glycerin, to ensure they are suitable for use in your drug products. Further, your incoming material…