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
Be Well Natural Medicine — FDA 483 Findings
Inspectors Jolanna A Norton · Dustin M JamesThe 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 engaged in aseptic processing were observed wearing non-sterile gloves.
3Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
4Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing area was located within a non-classified room (segregated production area).
About this record
Extracted automatically from the document US FDA published on 2022-11-28. 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.
