FDA Inspection
Delaware Valley Institute of Fertility & GeneticsDelaware Valley Institute of Fertility & Genetics – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Delaware Valley Institute of Fertility & Genetics, with an inspection on December 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 6, 2012
- Product Type
- Biologics
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ID · dee88082-1c58-4ec2-8b03-8e772044bcd3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809990
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Delaware Valley Institute of Fertility & Genetics
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 22, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 11, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 19, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 23, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Delaware Valley Institute of Fertility & Genetics
- FDA Inspection 1222056 - 2023-10-18
- FDA Inspection 1163836 - 2022-02-22
- FDA Inspection 1030482 - 2017-10-11
- FDA Inspection 958981 - 2016-01-19
- FDA Inspection 879779 - 2014-05-23
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