1Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean equipment or surface.
Inspection Record
Diplomat Pharmacy Inc. dba Diplomat Specialty Pharmacy — FDA 483 Findings
Inspectors Emily J Orban · Bei Y HeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
3Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
4Aseptic processing and sterility assurance
Inadequately protected product intended to be sterile was exposed to lower than ISO 5 classified aseptic processing area quality air.
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.
