Warning letter
Manhattan Reproductive Medicine, PC: warning letter of Nov 20, 2013
FDA warning letter 413797 · New York District Office
Key facts
| Reference number | 413797 |
|---|---|
| Company | Manhattan Reproductive Medicine, PC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Nov 20, 2013 |
| Posted date | Nov 20, 2013 |
| Issuing office | New York District Office |
| Product type | Biologics |
| CFR sections cited | 1271.80(c), 1271, 1271.3(n), 1271.55(a)(1), 1271.75(a)(1), 1271.50(a), 1271.80(d), 1271.80(d)(1), 1271.85(a) |
| Inspection city | New York |
| Inspection ZIP | 10021 |
| Inspection start date | Jul 26, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 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: