Equipment Operation

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination sterile drug product are not established and followed
Microbiology FDA 483 (Zydus Lifesciences): Appropriate controls are not exercised over computers or related systems
Microbiology FDA 483 (Zydus Lifesciences): Aseptic processing areas are deficient for monitoring environmental conditions
Microbiology FDA 483 (Zydus Lifesciences): Procedures to prevent microbiological contamination are not followed
Microbiology FDA 483 (Zydus Lifesciences): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process
Microbiology FDA 483 (Zydus Lifesciences): Established sampling plans and test procedures are not followed
Microbiology FDA 483 (Precision Equine LLC): Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination
Microbiology FDA 483 (Precision Equine LLC): Procedures to prevent microbiological contamination are not established; written and followed
Microbiology FDA 483 (Precision Equine LLC): No written testing program designed to assess the stability characteristics of drug products
Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed
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