Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed
On April 2, 2024 during post production manual cleaning of line *** RABS ID PR***RABS-001 used in the manufacture of
On April 2, 2024 during post production manual cleaning of line *** RABS ID PR***RABS-001 used in the manufacture of
Requalification of the *** Sterilization Process for *** Loads *** Bottle Formats) in the *** Model ***, Equipment ID# E-0832-W,
Specifically, your firm’s *** management reported it has no data to ensure clean/deactivation reagents and methods used within the ISO