Warning letter
Repromed Fertility Center: warning letter of Jul 28, 2014
FDA warning letter 431362 · Dallas District Office
Key facts
| Reference number | 431362 |
|---|---|
| Company | Repromed Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jul 28, 2014 |
| Posted date | Dec 16, 2014 |
| Issuing office | Dallas District Office |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.75, 1271.80, 1271.50(a), 1271.75(a), 1271.80(b) |
| Inspection city | Dallas |
| Inspection ZIP | 75204 |
| Inspection start date | Mar 27, 2014 |
| 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: