> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Dignity Health FDA-483 Released
- URL: https://www.fdaweb.com/dignity-health-fda-483-released/
- Published: 2017-11-29T12:00:00.000Z
- Updated: 2026-09-14T23:03:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140227

FDA has released the FDA-483 issued at the end of a 10/23-11/1 agency inspection at Northridge Hospital’s Dignity Health sterile drug products producer in Northridge, CA. Specific inspection observations were: 

- the facility design allowed the influx of poor quality air into a highly classified area;
- sinks or drains were present in the classroom where the ISO 5 classified aseptic processing area was located;
- the ISO 5 classified aseptic processing area was located within a non-classified room (segregated production area);
- unsealed, loose ceiling tiles were observed in the cloakroom;
- the facility was designed and/or operated in a way that permits poor flow of personnel;
- sporicidal agents were not used in the facility’s clean rooms and/or ISO 5 classified aseptic processing area;
- materials or supplies were not disinfected before entering the aseptic processing area;
- disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile;
- personnel engaged in aseptic processes were observed with exposed hair; and
- the segregated production areas surrounding the ISO 5 classified aseptic processing area contained dust-collecting overhangs without adequate and frequent cleaning.