FDA Inspection
University HealthUniversity Health – FDA Inspection, Oct 7, 2009
Record Details
This FDA Inspection record concerns University Health, with an inspection on October 7, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- University Health
- Inspection Date
- October 7, 2009
- Product Type
- Biologics
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ID · 82ee706b-cefd-4daf-afd8-f61e00cd6963
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 613782
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of University Health
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 9, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 29, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 21, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 21, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University Health
- FDA Inspection 1227949 - 2024-01-16
- FDA Inspection 1113085 - 2019-12-09
- FDA Inspection 1033960 - 2017-11-29
- FDA Inspection 954868 - 2015-12-21
- FDA Inspection 863244 - 2014-01-21
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