1Aseptic processing and sterility assurance
Non-sterilized and Non-depyrogenated equipment was used in sterile drug production.
Inspection Record
RC Compounding Services, LLC — FDA 483 Findings
Inspectors Matthew B Casale · Jazmine N StillThe 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
Personnel placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
3Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
4Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
5Contamination control
You produced highly potent drugs without providing adequate containment, cleaning of work surfaces and cleaning of personnel to prevent cross-contamination.
6Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
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.
