Environmental monitoring and personnel monitoring data is not reliable because of the materials used to conduct tests.
The location of your viable and nonviable particle sample collection points inside your ISO-5 *** Laminar Flow Hood in room
your firm fail to use biological indicators to ensure your firm’s glassware is endotoxin free by undergoing an adequate ***.
pecifically, during a review of our firm’s non-conformances we found your firm initiated a total of 4 Non-conformance reports for
pecifically, during a review of your firm’s environmental sampling results for your firm’s ISO 5 classified areas and equipment, we
Specifically, your firm’s *** management reported it has no data to ensure clean/deactivation reagents and methods used within the ISO
n 10/23/2023, during observation of your firm’s automated vial filling operation within your firm’s ISO 5 Cleanroom, for the drug
Specifically, on 11/13/2023, during a review of selected *** aseptically sterile lots that were produced within your firm’s Formulation Room
There are no controls to prevent operators from changing the date and time on the Climet non-viable particle count equipment.
Investigation Report APL-FU4-PNC-22-02** was opened when media fill batch *** (***mL vial), conducted on Line *** in Block *** was