FDA Inspection
Providence VA Healthcare SystemProvidence VA Healthcare System – FDA Inspection, Feb 28, 2013
Record Details
This FDA Inspection record concerns Providence VA Healthcare System, with an inspection on February 28, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 28, 2013
- Product Type
- Biologics
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ID · ab9f1155-595d-4d9c-a795-4e4db0ed94c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823637
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)(14)QC procedures for supplies and reagents
- 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 |
| March 27, 2017 | 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 |
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 1004781 - 2017-03-27
- FDA Inspection 923968 - 2015-04-16
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