FDA Inspection 1157834 — 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 November 30, 2021 in New York, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 30, 2021
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |