1Other quality system
Each lot of is not withheld from use until the lot has been sampled, tested.
Inspection Record
Central Admixture Pharmacy Services, Inc. — FDA 483 Findings
Inspectors Anita R. Michael · Tamara L. Ely · Akilah K. GreenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing, and holding ofdrug products is not appropriate for the duties they perform.
3Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
4Equipment and facility
Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary condition.
5Equipment and facility
The flow of components, drug product containers, closures, and drug products though the building is not designed to prevent contamination.
6Labeling and packaging
The labels for the drug products you produce do not contain information required by section SOJB(a)( 10).
7Aseptic processing and sterility assurance
Procedures des igned to prevent microbiological contamination of dru g products purporting to be sterile are not estab lished, written, a nd followed.
8Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
9Documentation and records
Batch production.and control records do not include complete information relating to the production and control ofeach batch.
10Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
11Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the prior to release.
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.
