Validation

Microbiology FDA 483 (Front Door Pharmacy): ISO-5 classified areas were not certified under dynamic conditions

Specifically, unidirectional airflow was not verified under operational conditions. Your firm’s clean room re certification reports tests dated 1/27/2021, 8/5/2020,

26/03/2024

Microbiology FDA 483 (Front Door Pharmacy): Facility design allowed the influx of poor-quality air into a higher classified area

Specifically, your firm air returns are adjacent to your HEPA filters in the ceiling of the ISO 8 Anteroom and

26/03/2024

Microbiology FDA 483 (Front Door Pharmacy): The use of sporicidal agents in aseptic processing area was inadequate

Specifically, your firm failed to validate the sporicidal agent, *** Sporicidal Disinfectant Cleaner for its intended use within the cleanroom

26/03/2024

Microbiology FDA 483 (Front Door Pharmacy): Media fills were not performed that closely simulate aseptic production operations

Specifically, your pharmacy fails to provide an adequate justification for your facility’s media fill program in order to simulate aseptic

26/03/2024

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 (Stokes Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting to produce aseptic conditions

Your firm has not conducted smoke studies nor media fills under dynamic conditions in rooms C704, and C706 where filling

24/03/2024

Microbiology FDA 483 (Stokes Healthcare): Procedures to prevent microbiological contamination are not established, written and followed

Your firm has not conducted smoke studies nor media fills under dynamic conditions in rooms C704, and C706 where filling

24/03/2024

Microbiology FDA 483 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

The designs of Vial Line *** systems ( ***), Vial Line *** (System ***), Flexible Fill Line *** (System ***),

23/03/2024

Microbiology FDA 483 (Eugia SEZ): Lack the training required to perform assigned functions

The ability of visual inspectors to identify integrity defects during visual inspection of ** Restricted Access Barmier System *** RABS)

22/03/2024

Microbiology FDA 483 (Front Door Pharmacy): ISO-5 classified areas were not certified under dynamic conditions

Microbiology FDA 483 (Front Door Pharmacy): Facility design allowed the influx of poor-quality air into a higher classified area

Microbiology FDA 483 (Front Door Pharmacy): The use of sporicidal agents in aseptic processing area was inadequate

Microbiology FDA 483 (Front Door Pharmacy): Media fills were not performed that closely simulate aseptic production operations

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 (Stokes Healthcare): Aseptic processing areas are deficient for cleaning and disinfecting to produce aseptic conditions

Microbiology FDA 483 (Stokes Healthcare): Procedures to prevent microbiological contamination are not established, written and followed

Microbiology FDA 483 (Catalent Indiana): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Eugia SEZ): Lack the training required to perform assigned functions

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