FDA Inspection
Dignity Health - Northridge Hospital Medical CenterDignity Health - Northridge Hospital Medical Center – FDA Inspection, Mar 11, 2016
Record Details
This FDA Inspection record concerns Dignity Health - Northridge Hospital Medical Center, with an inspection on March 11, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 11, 2016
- Product Type
- Drugs
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ID · bab379a8-38ba-45db-8bee-70e400e68f00
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 963109
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Dignity Health - Northridge Hospital Medical Center
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2017 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| August 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| 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 1030864 - 2017-11-07
- FDA Inspection 1024371 - 2017-08-30
- FDA Inspection 927975 - 2015-05-29
- FDA Inspection 794494 - 2012-08-13
- FDA Inspection 663947 - 2010-05-25
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