1Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
Inspection Record
Zions RX Formulations Services LLC dba Rx Formulation Serv. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
3Aseptic 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.
4Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
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 do not include adequate validation ofthe sterilization process.
7Equipment and facility
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and description in sufficient detail of the methods of disassembling and reassembling equipment as necessar y to assure proper cleaning and maintenance.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological con ination of drug products purporting to be sterile are not established.
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.
