1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Inspection Record
Banner Pharmacy Services, LLC — FDA 483 Findings
Inspectors Eileen A Liu · Ashar P Parikh · Nicholas L HuntThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The quality control unit lacks the responsibility and authority to approve and reject all drug products.
3Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
6Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for pyrogens are not written and followed.
7Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
9Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
10Laboratory and QC controls
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
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.
