1Stability and storage
An adequate number of batches ofeach drug product are not tested to determine an appropriate expiration date.
Inspection Record
Central Admixture Pharmacy Services, Inc. — FDA 483 Findings
Inspectors Bruce H. Mccullough · Russell K. RileyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under p ositive pressure.
3Material and supplier control
There is a failure to thoroughly review the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
4Aseptic 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.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
7Material and supplier control
There was a failure to handle and store components at all times in a manner to prevent contamination.
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.
