Specifically, non-viable monitoring excursions obtained during machine parts assembly of more than *** or *** successive events within *** were
Smoke studies are inadequate in that they do not demonstrate unidirectional air flow in the following instances
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Adequate scientific justification could not be provided for
Viewing of the aseptic filling area is only available through real time and previously recorded videos. During this inspection reviewed
Specifically, the media fill operation used to re-qualify one of your technicians for sterile operations on 08/24/22 consisted of the
On 11/28/22, an unsealed ceiling tile was observed directly above the ISO 5 biosafety cabinet (BSC) in your ISO 7
Your sterile non-hazardous and sterile hazardous cleanrooms, both of which are used to produce drug products purported to be sterile,
The ISO 5 hoods in your sterile non-hazardous cleanroom, both of which are used to produce drug products purported to
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