Quality System

Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Microbiology FDA 483 (Eugia Steriles): Control procedures are not established which validate the performance of those manufacturing processes
Microbiology FDA 483 (Eugia Steriles): Input to and output from the computer and records or data are not checked for accuracy
Microbiology FDA 483 (Eugia Steriles): Procedures to prevent microbiological contamination are not established and followed
Microbiology FDA 483 (Zydus Lifesciences): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination
Microbiology FDA 483 (Zydus Lifesciences): Buildings used in the manufacturing of a drug product are not maintained in a good state of repair
Microbiology FDA 483 (Zydus Lifesciences): Procedures designed to prevent microbiological contamination are not written and followed
Microbiology FDA 483 (Zydus Lifesciences): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Microbiology FDA 483 (Cipla Limited): Failure to clean and maintain equipment and utensils to prevent contamination
Microbiology FDA 483 (Alkem Laboratories): Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards,  test procedures
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