1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing did not use adequate aseptic techniques to ensure drug products remain sterile.
Inspection Record
Tri-Med Inc. dba Advanced Care Infusion-Shelby — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the aseptic processing areas are not sterile.
3Aseptic processing and sterility assurance
Equipment, materials, and/or supplies are not disinfected prior to entering the aseptic processing areas.
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.
