1Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO <Redacted B4> area.
Inspection Record
Empower Clinic Services LLC dba Empower Pharmacy — FDA 483 Findings
Inspectors Camerson E Moore · Oluwasefunm AgbanigoThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Microbial contamination was present in the ISO <Redacted B4> area.
3Training and personnel
Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.
4Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
5Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
About this record
Extracted automatically from the document US FDA published on 2025-12-18. 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.
