1Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
Inspection Record
Custom Compounding Center — FDA 483 Findings
Inspectors Jason R. CaballeroThe 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 validation of the sterilization process.
3Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
4Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
5Material and supplier control
Representative samples are not taken of each shipment of each lot of components for testing or examination.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
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.
