1Quality unit oversight
The quality control unit lacks the responsibility and authority to reject all drug products .
Inspection Record
US Compounding Inc. — FDA 483 Findings
Inspectors Massoud Motamed · Scott T. BallardThe 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
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
4Equipment and facility
Buildings used in the manufacture, processing.
5Aseptic processing and sterility assurance
Aseptic processing areas are defi cient regarding air supply tha t is filtered throu gh h ig h- effic ie nc y part ic ul at e ai r fi lte rs u nder 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.
