FDA Inspection
University of South Alabama Children's and Women's HospitalUniversity of South Alabama Children's and Women's Hospital – FDA Inspection, Feb 11, 2015
Record Details
This FDA Inspection record concerns University of South Alabama Children's and Women's Hospital, with an inspection on February 11, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 11, 2015
- Product Type
- Biologics
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ID · 4bdc34f6-b94a-4d9d-bc1e-026435a453aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 913526
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 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 University of South Alabama Children's and Women's Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 22, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 22, 2019 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 22, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 31, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University of South Alabama Children's and Women's Hospital
- FDA Inspection 1251679 - 2024-09-18
- FDA Inspection 1169075 - 2022-04-22
- FDA Inspection 1076900 - 2019-01-22
- FDA Inspection 1015575 - 2017-06-22
- FDA Inspection 834005 - 2013-05-31
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