FDA Inspection
Alta Bates Campus Lab of Alta Bates Summit Medical CenterAlta Bates Campus Lab of Alta Bates Summit Medical Center – FDA Inspection, Apr 2, 2014
Record Details
This FDA Inspection record concerns Alta Bates Campus Lab of Alta Bates Summit Medical Center, with an inspection on April 2, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 2, 2014
- Product Type
- Biologics
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ID · a2d7cddf-b918-4031-b579-a2b4438e99b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 874535
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Alta Bates Campus Lab of Alta Bates Summit Medical Center
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2024 | Not classified | San Francisco District Office | |
| June 7, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 12, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 17, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 3, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Alta Bates Campus Lab of Alta Bates Summit Medical Center
- FDA Inspection 1257096 - 2024-11-13
- FDA Inspection 1171551 - 2022-06-07
- FDA Inspection 1059961 - 2018-07-12
- FDA Inspection 977566 - 2016-06-17
- FDA Inspection 809414 - 2012-12-03
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