FDA Inspection
Dignity Health - Northridge Hospital Medical CenterDignity Health - Northridge Hospital Medical Center – FDA Inspection, Nov 7, 2017
Record Details
This FDA Inspection record concerns Dignity Health - Northridge Hospital Medical Center, with an inspection on November 7, 2017, issued by the Los Angeles District Office, covering human drugs.
- Inspection Date
- November 7, 2017
- Product Type
- Human Drugs
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ID · d0f9869b-d596-4f0a-8226-5573c00d9726
Inspection Facts
- Inspection number
- 1030864
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- FDCA 501(a)(2)(A)Air flow quality, higher classified area
- FDCA 501(a)(2)(A)Ceiling tiles, cleanroom
- FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)Dust-collecting overhangs, surrounding area of ISO 5
- FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
- FDCA 501(a)(2)(A)Flow of personnel and materials, facility
- FDCA 501(a)(2)(A)Location, ISO 5 classified area
- FDCA 501(a)(2)(A)No sporicidal agents, cleanroom and ISO 5 area
- FDCA 501(a)(2)(A)Sinks, drains in cleanroom of ISO 5 area
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Other FDA inspections of Dignity Health - Northridge Hospital Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 11, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 13, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 25, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Dignity Health - Northridge Hospital Medical Center
- FDA Inspection 1024371 - 2017-08-30
- FDA Inspection 963109 - 2016-03-11
- FDA Inspection 927975 - 2015-05-29
- FDA Inspection 794494 - 2012-08-13
- FDA Inspection 663947 - 2010-05-25
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