1Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
Inspection Record
Accurate RX Pharmacy Consulting LLC — FDA 483 Findings
Inspectors Constantin Y PhilopoulosThe 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
The ISO 5 classified aseptic processing area was located within a non-classified room (segregated production area).
3Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
About this record
Extracted automatically from the document US FDA published on 2020-05-04. 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.
