Environment monitoring

Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for environment monitoring

Environmental monitoring sampling locations have not been selected considering routine aseptic operations and interventions. Locations for surface monitoring that have

26/02/2024

Microbiology FDA 483 (Kilitch Healthcare) : Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures

Environmental monitoring and personnel monitoring data is not reliable because of the materials used to conduct tests.

22/02/2024

Microbiology FDA 483 (STAQ Pharma) : Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

The location of your viable and nonviable particle sample collection points inside your ISO-5 *** Laminar Flow Hood in room

21/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Inadequate post-use * testing on * used to sterilized drug products

pecifically, during a review of our firm’s non-conformances we found your firm initiated a total of 4 Non-conformance reports for

20/02/2024

Microbiology FDA 483 (Empower Clinic Services) : Inadequate routine environmental monitoring in the ISO 5 area and classified areas

pecifically, during a review of your firm’s environmental sampling results for your firm’s ISO 5 classified areas and equipment, we

20/02/2024

Microbiology FDA 483 : Lack of assurance of manufacturing operations – prevention of contamination of equipment or product by environmental and processing conditions

12/02/2024

Microbiology FDA 483 (Kilitch Healthcare): Aseptic processing areas are deficient for environment monitoring

Microbiology FDA 483 (Kilitch Healthcare) : Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures

Microbiology FDA 483 (STAQ Pharma) : Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Empower Clinic Services) : Inadequate post-use * testing on * used to sterilized drug products

Microbiology FDA 483 (Empower Clinic Services) : Inadequate routine environmental monitoring in the ISO 5 area and classified areas

Microbiology FDA 483 : Lack of assurance of manufacturing operations – prevention of contamination of equipment or product by environmental and processing conditions

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