FDA Inspection
Gramercy Fertility ServicesGramercy Fertility Services – FDA Inspection, Mar 22, 2012
Record Details
This FDA Inspection record concerns Gramercy Fertility Services, with an inspection on March 22, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Gramercy Fertility Services
- Inspection Date
- March 22, 2012
- Product Type
- Biologics
View Company Profile
ID · 6ec019ea-ed3b-45ac-9203-fea76645e177
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 772372
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.75(a)(2)Risks associated with xenotransplantation
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gramercy Fertility Services
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 1, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 8, 2014 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 29, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 25, 2011 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Gramercy Fertility Services
- FDA Inspection 1021259 - 2017-06-07
- FDA Inspection 989742 - 2016-11-01
- FDA Inspection 878293 - 2014-05-08
- FDA Inspection 788892 - 2012-06-29
- FDA Inspection 726027 - 2011-05-25
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