Specifically, your film utilizes *** that are not directly supplied with HEPA-filtered air and rely on a passive supply from
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,
Specifically, your firm air returns are adjacent to your HEPA filters in the ceiling of the ISO 8 Anteroom and
Specifically, your firm failed to validate the sporicidal agent, *** Sporicidal Disinfectant Cleaner for its intended use within the cleanroom
Specifically, environmental Monitoring and measurement frequency of microbiological contamination (viable/non-viable monitoring) of the air in the ISO 5 zone is
Specifically, your pharmacy fails to provide an adequate justification for your facility’s media fill program in order to simulate aseptic
Specifically, during the visual sterile production observation of the finished sterile drug product, P105 (PAP30MG/ PHE1MG/ PGE10MCG), Lot # 051321@***,
Specifically, your quality unit did not follow its own procedure, POL-QA-1005 Quality Unit Policy which defines the responsibilities of all
Specifically, according to the Microbiology Supervisor, your firm has not conducted a risk assessment or an environmental monitoring qualification that
Specifically, your firm’s recent certification documentation: Clean Room Certification Report RM C704 *** (Room C704), Cleanroom Certification Report RM ***