1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed .
Inspection Record
Central Admixture Pharmacy Services, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Samples taken ofdrug products for determination ofconformance to written specifications are not representative.
3Material and supplier control
Each Jot ofcomponents was not appropriately identified as to its status in terms of being quarantined, approved or rejected .
4Equipment and facility
The operations relating to the processing and packing of penicillin are not perfom1ed in facilities sepa rate from those used for other drug products for human use.
5Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications designed to assure that components conform to appropriate standards ofidentity, strength, quality and purity.
6Equipment and facility
Buildings used in the manufacture, processing, packing, or holding ofa drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
7Other quality system
Written distribution procedures are not followed.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.
9Contamination control
Protective apparel is not worn as necessary to protect drug products fro m contamination.
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.
