1Aseptic processing and sterility assurance
Inadequate aseptic practices were observed.
Inspection Record
Magellan Rx Pharmacy LLC — FDA 483 Findings
Inspectors Mindy Chou · Rachael MoliverThe 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
There is an inadequate facility design and equipment use for sterile operation.
3Aseptic processing and sterility assurance
Your firm fails to have adequate cleaning and disinfecting practices in the aseptic processing areas.
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.
