Review of the non-viable particle count (NVPC) continuous monitoring from the ***, which is used to transport *** vials from
During walk-through of the facility on 8/23/2023, contamination was observed in your sterile and non-sterile areas for the following:
Unknown
On 04-Dec-2023, observed about 450 mL of *** “stagnant liquid” partially covered in sections with *** layers inside the Air
On 25 August 2023, observed was ceiling port cover dislodged in Grade B space, directly over where Plant *** (Fill
Specifically, cleaning procedures for the cleaning of *** RAB/RAB and the aseptic area do not contain enough detail to ensure
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
On July 11, 2023, during the walk-through observed broken wooden pallets used to store drug product components in the receiving
Specifically, on July 16, 2023, observed the following during the *** cleaning:
(A) Rust on the stainless-steel pole that held