Clean Room

Microbiology FDA 483 (Stokes Healthcare): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Specifically, your quality unit did not follow its own procedure, POL-QA-1005 Quality Unit Policy which defines the responsibilities of all

24/03/2024

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure

Specifically, your firm’s recent certification documentation: Clean Room Certification Report RM C704 *** (Room C704), Cleanroom Certification Report RM ***

24/03/2024

Microbiology FDA 483 (Kilitch Healthcare): Buildings used in the manufacture of drug products are not maintained in a clean and sanitary condition

On October 13, 2023 it was observed during a production area walkthrough that the *** floor in the Grade B

25/02/2024

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 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 (Stokes Healthcare): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Microbiology FDA 483 (Stokes Healthcare): Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure

Microbiology FDA 483 (Kilitch Healthcare): Buildings used in the manufacture of drug products are not maintained in a clean and sanitary condition

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

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

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

Microbiology FDA 483 (Sun Pharmaceutical): Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination