Laboratory records are not completed contemporaneously and do not include complete data derived from all tests to assure compliance with
Your facility is designed and operated in a way that may permit the influx of lesser quality air into a
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case most-challenging, and stressful conditions
Smoke studies were inadequately performed under dynamic conditions
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 ***
You have not performed a cleaning validation for the glassware washer (Smeg Model #GW3060S, ID #T****) located in the Microbiology
You have not performed ** ( integrity testing for holes and leaks for the ) ( utilized in the /RABS
When counting microbial plates for colonies (CFU/mL) in your Microbiological Lab, a calculation is performed to determine the CFU/ml results