Specifically, inside the aseptic area used in the manufacture of *** Injection, ***mg/vial, a box (approximately ****), is outlined on
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
Specifically, determination of conformance to written specifications are deficient for TAMC (Total Aerobic Microbial Count) test and TYMC (Total Yeast
During aseptic filling operations, procedure HO-CQA-SOP-2*** “Clean Room Practices and Aseptic Behavior” and line specific intervention procedures were not followed:
Environmental/personnel monitoring for Building *** RABS Filling Line *** is not adequate
You failed to appropriate clean and maintain *** incubator (ID #***), which is utilized to incubate microbial plates for ***