FDA Inspection 1237978 — The Center For Human Reproduction D.B.A. American Infertility Of New York, P.C.
The FDA completed an inspection of The Center For Human Reproduction D.B.A. American Infertility Of New York, P.C. on May 1, 2024 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |