Warning letter
Family Fertility Center: warning letter of Sep 30, 2019
FDA warning letter 588805 · Division of Biological Products Operations II
Key facts
| Reference number | 588805 |
|---|---|
| Company | Family Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Sep 30, 2019 |
| Posted date | Oct 8, 2019 |
| Issuing office | Division of Biological Products Operations II |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.155, 1271.3(s), 1271.47(a), 1271.75(a)(1), 1271.3(r)(2), 1271.50(a), 1271.60(a), 1271.90(b), 1271.90(c) |
| Inspection city | Houston |
| Inspection ZIP | 77030 |
| Inspection start date | Jun 18, 2019 |
| 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: