1Contamination control
You produced hazardous drugs without providing adequate cleaning of work surfaces to prevent cross-contamination.
Inspection Record
Johnson Memorial Cancer Center — FDA 483 Findings
Inspectors Jonathan G MatriscianoThe 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
Disinfecting agents used in the ISO 5 classified aseptic processing areas were not sterile.
4Aseptic processing and sterility assurance
You had inadequate HEP A filter coverage and airflow over the area to which sterile product was exposed.
About this record
Extracted automatically from the document US FDA published on 2022-01-28. 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.
