Warning letter
Exela Pharma Sciences, LLC: warning letter of Jul 2, 2025
FDA warning letter 709859 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 709859 |
|---|---|
| Company | Exela Pharma Sciences, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 2, 2025 |
| Posted date | Jul 3, 2025 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 210.1(b), 200.10(b), 211.25(a), 211.100(a), 211.165(d), 211.166(a), 211.167(a), 211.192, 211.194(a), 211.194(a)(8) |
| Inspection city | Lenoir |
| Inspection ZIP | 28645 |
| Inspection start date | Nov 4, 2024 |
| 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: