1Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Inspection Record
Central Admixture Pharmacy Services, Inc. (CAPS) — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the identity and strength of each active ingredient prior to release.
4Laboratory and QC controls
Reserve samples for drug products are not retained for one year after the expiration date of the drug product.
5Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
6Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
8Equipment and facility
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding ofa drug product.
9Laboratory and QC controls
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit.
10Contamination control
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination ofdrug products.
11Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory , testing.
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.
