1Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for th e duties they perform.
Inspection Record
Central Admixture Pharmacy Services, Inc. — FDA 483 Findings
Inspectors Kendra L. Brooks · Junho PakThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
3Documentation and records
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of th e appropriate master production or control record which was checked for accuracy, dated and signed.
4Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformanceto such requirements.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
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.
