FDA Inspection
Providence Health System Southern CaliforniaProvidence Health System Southern California – FDA Inspection, Sep 27, 2011
Record Details
This FDA Inspection record concerns Providence Health System Southern California, with an inspection on September 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 27, 2011
- Product Type
- Biologics
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ID · ddf7a718-a188-415b-b67d-b9e33ea83ae0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 747074
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 600.14(c)When to report
- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Providence Health System Southern California
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 28, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 17, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Providence Health System Southern California
- FDA Inspection 1028064 - 2017-09-19
- FDA Inspection 927659 - 2015-05-28
- FDA Inspection 829295 - 2013-04-17
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