1Deviation, CAPA, and investigation
Written.records are not always made ofinvestigations into unexplained discrepancies and the failure of a batch or any.
Inspection Record
Auro Pharmacies Inc. — FDA 483 Findings
Inspectors Liming ZhangThe 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 responsibilities and procedures applicable to the quality control unit are not fully followed.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring envionmental conditions.
4Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and.
5Laboratory 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.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
7Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy .
8Equipment and facility
The flow of drug product containers and closures though the building is not designed to prevent contamination.
9Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile not established and followed.
11Stability and storage
Results of stability testing are not used in determining expiration dates.
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.
