FDA Inspection
Advanced Reproductive Medicine & Surgery, P.C.Advanced Reproductive Medicine & Surgery, P.C. – FDA Inspection, Jan 14, 2011
Record Details
This FDA Inspection record concerns Advanced Reproductive Medicine & Surgery, P.C., with an inspection on January 14, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 14, 2011
- Product Type
- Biologics
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ID · 527b7c43-cd7f-4c34-8ba0-fa140f277b70
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 710024
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.55(d)(1)(iii)Documentation--determination, by whom, date
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Advanced Reproductive Medicine & Surgery, P.C.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 13, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 3, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Advanced Reproductive Medicine & Surgery, P.C.
- FDA Inspection 1068575 - 2018-09-11
- FDA Inspection 974552 - 2016-04-13
- FDA Inspection 868295 - 2014-03-03
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