FDA Inspection
Yale Center For Reproductive Medicine & InfertilityYale Center For Reproductive Medicine & Infertility – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns Yale Center For Reproductive Medicine & Infertility, with an inspection on February 19, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 19, 2016
- Product Type
- Biologics
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ID · d7f7b31e-3881-4f35-813b-222c1bdc5508
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 959460
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of Yale Center For Reproductive Medicine & Infertility
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 23, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 15, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 24, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 24, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Yale Center For Reproductive Medicine & Infertility
- FDA Inspection 1216884 - 2023-08-28
- FDA Inspection 1129860 - 2020-09-23
- FDA Inspection 1045768 - 2018-03-15
- FDA Inspection 833179 - 2013-05-24
- FDA Inspection 710786 - 2011-02-24
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