1Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
Inspection Record
United Pharmacy, LLC — FDA 483 Findings
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.
3Contamination control
Personnel failed to disinfect or change gloves frequently enough to prevent contamination.
4Aseptic processing and sterility assurance
Environmental monitoring was not adequately performed in your aseptic processing areas.
5Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
6Aseptic processing and sterility assurance
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic production without adequate product evaluation and remedial action.
7Other quality system
Post <Redacted B4> testing to <Redacted B4> was not performed adequately.
8Aseptic processing and sterility assurance
Equipment, materials, and/or supplies are not disinfected prior to entering 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.
