FDA Inspection
Offices for Fertility and Reproductive Medicine, P. C.Offices for Fertility and Reproductive Medicine, P. C. – FDA Inspection, Jan 31, 2018
Record Details
This FDA Inspection record concerns Offices for Fertility and Reproductive Medicine, P. C., with an inspection on January 31, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 31, 2018
- Product Type
- Biologics
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ID · dc2031eb-68db-4124-ae4f-270f695f0639
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039314
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Offices for Fertility and Reproductive Medicine, P. C.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 12, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 25, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 28, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Offices for Fertility and Reproductive Medicine, P. C.
- FDA Inspection 962764 - 2016-03-18
- FDA Inspection 878286 - 2014-05-12
- FDA Inspection 800591 - 2012-09-25
- FDA Inspection 615020 - 2009-09-28
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