1Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
Inspection Record
Dignity Health-Northridge Hospital Medical Center — FDA 483 Findings
Inspectors Andrew K Haack · Uttaniti LimchumroonThe 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).
3Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
4Aseptic processing and sterility assurance
Sinks or drains we present in the cleanroom where the ISO 5 classified aseptic processing area was lo cated.
5Equipment and facility
Your facility design allowed the influx of poor quality air into a higher classified area.
6Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel.
7Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
8Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
9Aseptic processing and sterility assurance
The segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.
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.
