Warning letter
Zhang Medical P.C. dba New Hope Fertility Center: warning letter of Jun 24, 2022
FDA warning letter 633890 · Office of Biological Products Operations – Division 1
Key facts
| Reference number | 633890 |
|---|---|
| Company | Zhang Medical P.C. dba New Hope Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jun 24, 2022 |
| Posted date | Jul 26, 2022 |
| Issuing office | Office of Biological Products Operations – Division 1 |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.50, 1271.75, 1271.80, 1271.85, 1271.155, 1271.3(s), 1271.75(a)(1), 1271.3(r)(2), 1271.50(a), 1271.55(b)(4), 1271.60(a) and 6 more |
| Inspection city | New York |
| Inspection ZIP | 10019 |
| Inspection start date | Nov 1, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: