Warning letter
EyePoint Pharmaceuticals, Inc.: warning letter of Jul 12, 2024
FDA warning letter 679747 · Office of Pharmaceutical Quality Operations Division I
Key facts
| Reference number | 679747 |
|---|---|
| Company | EyePoint Pharmaceuticals, Inc. |
| Subject | CGMP/Drugs/Adulterated |
| Issue date | Jul 12, 2024 |
| Posted date | Aug 27, 2024 |
| Issuing office | Office of Pharmaceutical Quality Operations Division I |
| Product type | Drugs |
| CFR sections cited | 4, 211.34, 211.192, 211.100(a), 211.110(a) |
| Inspection city | Watertown |
| Inspection ZIP | 02472-2468 |
| Inspection start date | Feb 6, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: