1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Banner Pharmacy Services, LLC — FDA 483 Findings
Inspectors Marcus F. Yambot · Joseph M. AllenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacture, processing, packing or holdiug ofdrug products are not maintained in a clean and sanitary condition.
3Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered tlu·ough high-efficiency particulate air fllters under positive pressure.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Documentation and records
The master production and control records are deficient in that they do not include complete instructions.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established.
8Quality unit oversight
The responsibilities and procedmes applicable to the quality control unit are not in writing and fully follower!.
9Equipment and facility
The labels and containers ofyour outso1u·cing facility's drug products do not include infonnation required by section 503B(a)(lO)(A) and (B).
10Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any ofits components to meet any ofits specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
