Warning letter
Eosera, Inc.: warning letter of Jul 13, 2020
FDA warning letter 605500 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 605500 |
|---|---|
| Company | Eosera, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 13, 2020 |
| Posted date | Jul 28, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.100(a), 211.166(a), 201.128, 211.34, 211.192, 344, 211.22(a) |
| Inspection city | Fort Worth |
| Inspection ZIP | 76115 |
| Inspection start date | Jan 13, 2020 |
| 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: