Warning letter
Ava Inc.: warning letter of Apr 14, 2026
FDA warning letter 721180 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 721180 |
|---|---|
| Company | Ava Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 14, 2026 |
| Posted date | May 5, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.22(a), 211.68(b), 211.160(a), 211.160(b), 211.192, 211.194(a) |
| Inspection city | Willowbrook |
| Inspection ZIP | 60527 |
| Inspection start date | Oct 6, 2025 |
| 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: