FDA Inspection
Reproductive Genetics and Fertility Centers PLLCReproductive Genetics and Fertility Centers PLLC – FDA Inspection, Aug 26, 2011
Record Details
This FDA Inspection record concerns Reproductive Genetics and Fertility Centers PLLC, with an inspection on August 26, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 26, 2011
- Product Type
- Biologics
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ID · 26aac14a-192b-4096-b28e-3ee47083e648
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 744498
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.47(d)Departures: recording and justifying
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.90(c)(1)Autologous use only--labeling
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Reproductive Genetics and Fertility Centers PLLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 24, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 10, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Reproductive Genetics and Fertility Centers PLLC
- FDA Inspection 981953 - 2016-08-03
- FDA Inspection 923218 - 2015-04-24
- FDA Inspection 834878 - 2013-06-10
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