1Aseptic processing and sterility assurance
Use of <Redacted B4> that are not sterilized by routine sterilization cycles and protected from contamination by sterilizing <Redacted B4> on vacuum break air lines/vents.
Inspection Record
Revive Rx LLC — FDA 483 Findings
Inspectors Sangeeta M KhuranaThe 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 5 area and areas adjacent to production areas.
3Aseptic processing and sterility assurance
Smoke studies were not performed under dynamic conditions.
4Aseptic processing and sterility assurance
Sterile drugs and Materials were exposed to lower than ISO 5 quality air.
5Training and personnel
Lack of adequate personnel sampling.
About this record
Extracted automatically from the document US FDA published on 2026-04-22. 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.
