Microbiology FDA 483 : Procedures to prevent microbiological contamination of sterile drug products are not established
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established
You failed to appropriate clean and maintain *** incubator (ID #***), which is utilized to incubate microbial plates for ***
You have not performed a cleaning validation for the glassware washer (Smeg Model #GW3060S, ID #T****) located in the Microbiology