Quality System

Microbiology FDA 483 (Alkem Laboratories): Responsibilities and procedures applicable to the quality control unit are not in writing and fully
Microbiology FDA 483 (Jubilant Generics): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed
Microbiology FDA 483 (Contract Pharmaceuticals): Failure to thoroughly review any unexplained discrepancy
Microbiology FDA 483 (Wedgewood Connect): Procedures to prevent microbiological contamination of drug products purporting to be sterile are not established and followed
Microbiology FDA 483 (Wedgewood Connect): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Microbiology FDA 483 (Wedgewood Connect): Written records are not always made of investigations into unexplained discrepancies
Microbiology FDA 483 (Wedgewood Connect): Aseptic areas are deficient for cleaning and disinfecting the room and equipment to produce aseptic conditions
Microbiology FDA 483 (Biocon Sdn.): Fails to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods
Microbiology FDA 483 (Biocon Sdn.): Failure to have written procedures for connective and preventative actions during loss or reversals of different pressure in classified aseptic areas
Microbiology FDA 483 (Biocon Sdn.): Procedures to prevent microbiological contamination are not established, written, or followed
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