1Contamination control
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
Inspection Record
Empower Clinic Services, LLC — FDA 483 Findings
Inspectors Demario L Walls · Saundrea A MunroeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
Inadequate routine environmental monitoring in the ISO 5 area.
3Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
4Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
5Aseptic processing and sterility assurance
Smoke studies were not and were inadequately performed under dynamic conditions.
6Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
7Validation and qualification
Lack of routine certification of the ISO 5 area.
8Other quality system
Use of ingredients not intended for phannaceutical use in non-sterile drug production.
About this record
Extracted automatically from the document US FDA published on 2025-02-07. 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.
