Microbiology FDA 483 (Zydus Lifesciences): Appropriate controls are not exercised over computers or related systems
The MODA software system is used for microbiology documentation of sampling and testing for the *** system *** and environmental
The MODA software system is used for microbiology documentation of sampling and testing for the *** system *** and environmental
Calibration certificates issued on Monday April 1 2024 of *** ES-PR-*** (location filling zone ***) and ES-PR-*** (location filling zone
On Jul 26, 2023, observed a Microbiology technician use another technician’s sign in for the *** Particulate Matter system to
There are no controls to prevent operators from changing the date and time on the Climet non-viable particle count equipment.