FDA Inspection
Providence VA Healthcare SystemProvidence VA Healthcare System – FDA Inspection, Mar 27, 2017
Record Details
This FDA Inspection record concerns Providence VA Healthcare System, with an inspection on March 27, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 66090161-7283-4c11-860b-40622c6bafac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1004781
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Providence VA Healthcare System
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 25, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| October 30, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 16, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 28, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Providence VA Healthcare System
- FDA Inspection 1235113 - 2024-04-02
- FDA Inspection 1165932 - 2022-03-25
- FDA Inspection 1070312 - 2018-10-30
- FDA Inspection 923968 - 2015-04-16
- FDA Inspection 823637 - 2013-02-28
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