1Contamination control
Microbial contamination was present in the ISO 5 area and areas adjacent to production areas.
Inspection Record
Revive Rx LLC — FDA 483 Findings
Inspectors Jazmine N BrownThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Smoke studies were not performed under dynamic conditions.
3Environmental monitoring
Lack of and Inadequate routine environmental monitoring in the ISO 5 area and classified areas.
4Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
5Equipment and facility
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
6Aseptic processing and sterility assurance
Use of lyophilizers that are not sterilized by routine sterilization cycles and protected from contamination by sterilizing filters on vacuum break air lines/vents.
7Aseptic processing and sterility assurance
Sterile drugs and Materials were exposed to lower than ISO 5 quality air.
About this record
Extracted automatically from the document US FDA published on 2025-03-28. 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.
