FDA Inspection
Kaiser Foundation HospitalKaiser Foundation Hospital – FDA Inspection, Dec 11, 2008
Record Details
This FDA Inspection record concerns Kaiser Foundation Hospital, with an inspection on December 11, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Kaiser Foundation Hospital
- Inspection Date
- December 11, 2008
- Product Type
- Biologics
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ID · b19665d8-1f7f-4598-a2cc-7e622cfca3b1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 556113
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(20)Donor deferral
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Kaiser Foundation Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 3, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 24, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 19, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 18, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Kaiser Foundation Hospital
- FDA Inspection 1340190 - 2026-10-06
- FDA Inspection 1301530 - 2026-02-03
- FDA Inspection 1265211 - 2025-03-24
- FDA Inspection 1263161 - 2025-02-19
- FDA Inspection 1258364 - 2024-12-18
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