1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply is through high-efficiency particulate air filters under positive pressure.
Inspection Record
Abbott's Compounding Pharmacy Inc. — FDA 483 Findings
Inspectors Ashar P Parikh · Eileen A Liu · Dustin P TranThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Specifically, your firm does not bear appropriate expiration dates on your sterile drug products.
3Equipment and facility
Buildings used the manufacturing and processing of a drug product are not maintained in a good state of repair.
4Laboratory 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.
5Aseptic processing and sterility assurance
Specifically, your firm has not established and does not follow procedures for cleaning, sterilizing, and depyrogenation of glassware used to produce sterile drug products.
6Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
7Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
9Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
