Warning letter
Strong Fertility Center: warning letter of Oct 29, 2019
FDA warning letter 593262 · Office of Biological Products Operations – Division I
Key facts
| Reference number | 593262 |
|---|---|
| Company | Strong Fertility Center |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Oct 29, 2019 |
| Posted date | Nov 5, 2019 |
| Issuing office | Office of Biological Products Operations – Division I |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.155, 1271.75(a)(1), 1271.45(c), 1271.60(a), 1271.85(a), 1271.90(b), 1271.90(c) |
| Inspection city | Rochester |
| Inspection ZIP | 14623 |
| Inspection start date | Aug 12, 2019 |
| Letter on fda.gov | fda.gov |
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: