1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Central Admixture Pharmacy Services Inc. — FDA 483 Findings
Inspectors Anita R. Michael · Deborah J. ParrisThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary con dition.
3Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for the duties they perform.
4Equipment and facility
The flow of components, drug product containers, closures, and drug products though the building is not designed to prevent contamination.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
6Material and supplier control
Each lot of a component, drug product container, and closure that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
7Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
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.
