1Documentation and records
Procedures for the preparation of master production and control records are not described in a written procedure.
Inspection Record
Central Admixture Pharmacy Services Inc — FDA 483 Findings
Inspectors Joey V QuitaniaThe 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
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
3Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt of components, drug product containers and closures.
4Laboratory and QC controls
Laboratory records are deficient in that they do not include a complete record ofall data obtained during testing.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
