FDA Inspection
Advanced Fertility Group, PCAdvanced Fertility Group, PC – FDA Inspection, Apr 13, 2011
Record Details
This FDA Inspection record concerns Advanced Fertility Group, PC, with an inspection on April 13, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Advanced Fertility Group, PC
- Inspection Date
- April 13, 2011
- Product Type
- Biologics
View Company Profile
ID · 62bb057a-2a3c-4253-ab6a-cec47474c407
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 718197
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.85(c)Reproductive cells or tissues
- 21 CFR 1271.85(b)(2)Cytomegalovirus (CMV)
- 21 CFR 1271.85(c)Reproductive cells or tissues-cell-associated CD
- 21 CFR 1271.85(a)Infection with communicable disease agents
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advanced Fertility Group, PC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 17, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 19, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 17, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Advanced Fertility Group, PC
- FDA Inspection 1062331 - 2018-08-02
- FDA Inspection 963290 - 2016-03-17
- FDA Inspection 856095 - 2013-11-19
- FDA Inspection 753547 - 2011-11-17
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