FDA Inspection 726027 — Gramercy Fertility Services
The FDA completed an inspection of Gramercy Fertility Services on May 25, 2011 in New York, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 25, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12281 | 21 CFR 1271.75(c) | Reproductive cells/tissues-Chlamydia, Neisseria |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |