1Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies.
Inspection Record
Central Admixture Pharmacy Services Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Batch production and control records do not include the specific identification of each batch of in process material used for each batch of drug product produced.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the ro om and equipment to produce aseptic conditions.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Equipment and facility
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between in-process materials and to prevent contamination.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and 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.
