Warning letter
The New Hope Center for Reproductive Medicine: warning letter of Jun 27, 2023
FDA warning letter 658251 · Division of Biological Products Operations I
Key facts
| Reference number | 658251 |
|---|---|
| Company | The New Hope Center for Reproductive Medicine |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jun 27, 2023 |
| Posted date | Jul 11, 2023 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.47, 1271.75, 1271.80, 1271.155, 1271.3(s), 1271.47(a), 1271.50(a), 1271.60(a), 1271.75(a), 1271.80(b), 1271.90(b) and 1 more |
| Inspection city | Virginia Beach |
| Inspection ZIP | 23452 |
| Inspection start date | Dec 8, 2022 |
| 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: