FDA Inspection 895283 — Zhang Medical P.C. d/b/a New Hope Fertility Center
The FDA completed an inspection of Zhang Medical P.C. d/b/a New Hope Fertility Center on September 15, 2014 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
- September 15, 2014
- Fiscal Year
- 2014
- 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 |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12281 | 21 CFR 1271.75(c) | Reproductive cells/tissues-Chlamydia, Neisseria |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |