1Other quality system
Drug held under environmental conditions whereby it may have been rendered injurious to health.
Inspection Record
Boothwyn Pharmacy LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Sterile drugs and materials were exposed to lower than ISO 5 quality air.
3Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
4Other 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.
5Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
About this record
Extracted automatically from the document US FDA published on 2025-08-07. 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.
