1Contamination control
You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contamination.
Inspection Record
Kelley-Ross & Associates, Inc. dba Kelley-Ross Compounding Pharmacy — FDA 483 Findings
Inspectors Christopher R CzajkaThe 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
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
3Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty equipment or surface.
4Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
5Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
About this record
Extracted automatically from the document US FDA published on 2021-01-29. 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.
