1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Premier Pharmacy Labs, Inc. — FDA 483 Findings
Inspectors Michael H. TallonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteri stics of dn.1g products.
3Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing ofdrug products.
4Contamination control
Protective apparel is not wom as necessary to protect dtug products from contamination.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
6Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of d.tug products purporting to be sterile are not established, written, and followed .
8Laboratory and QC controls
Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is fJ.ltered tlu·ough high-efficiency particulate air filters under positive pressure.
10Aseptic processing and sterility assurance
There are no written standards or specifications, methods oftesting, methods of cleaning, and methods of sterilization to remove pyrogenic properties.
11Documentation and records
Batch production and control records are not prepared for each batch of drug product produced and do not include complete info1mation relating to the production and control of each batch.
12Labeling and packaging
The labels of your outsourcing facility's drug products do not contain the following information required by section 503B(a)(10) ofthe Act: A.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
14Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation ofthe sterilization process.
15Equipment and facility
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed t o assure proper perfonnance.
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.
