Specifically, on July 16, 2023, observed the following during the *** cleaning:
(A) Rust on the stainless-steel pole that held
Brown substance was observed inside your grey reusable spray bottles filled with the *** solution. On July 11, 2023, observed
Your aseptic operators disinfect ISO 5 surfaces prior to environmental monitoring sample collection. This practice can yield false-negative results. For
Your *** stability program does not include sterility or endotoxin testing at the endpoint. Your firm only tests sterility and
Your firm’s Quality Unit failed to perform a method transfer of your sterility test method used for release of drug
Your firm failed to provide scientific evidence that endotoxin specification for products intended for epidural administration is adequate. Specifically,
Your ISO 5 aseptic operators failed to demonstrate adequate aseptic technique. For example:
On July 11, 2023, two (2) of
Your Quality Unit failed to thoroughly investigate instances of microbiological contamination within critical ISO 5 areas during aseptic production of
Specifically, your firm failed to establish and/or follow adequate written gowning procedures pertaining to the core manufacturing areas to ensure
Specifically, accuracy, sensitivity, specificity, and reproducibility of TAMC (Toral Aerobic Microbial Count) test used to routinely test *** for the