FDA Inspection
Center For Advanced Reproductive Medicine & FertilityCenter For Advanced Reproductive Medicine & Fertility – FDA Inspection, Feb 11, 2016
Record Details
This FDA Inspection record concerns Center For Advanced Reproductive Medicine & Fertility, with an inspection on February 11, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 11, 2016
- Product Type
- Biologics
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ID · a3226dbf-f2d8-4bdd-94cc-d6b614b6fc3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958542
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Center For Advanced Reproductive Medicine & Fertility
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 14, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 19, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 25, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Center For Advanced Reproductive Medicine & Fertility
- FDA Inspection 1244251 - 2024-07-15
- FDA Inspection 1167958 - 2022-04-14
- FDA Inspection 1096785 - 2019-07-19
- FDA Inspection 1002162 - 2017-03-03
- FDA Inspection 888758 - 2014-07-25
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