Warning letter
Island Kinetics, Inc. d.b.a. CoValence Laboratories: warning letter of Jul 16, 2026
FDA warning letter 726379 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 726379 |
|---|---|
| Company | Island Kinetics, Inc. d.b.a. CoValence Laboratories |
| Subject | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Issue date | Jul 16, 2026 |
| Posted date | Jul 21, 2026 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 201.128, 211.34, 211.100(a), 211.192 |
| Inspection city | Chandler |
| Inspection ZIP | 85224 |
| Inspection start date | Jan 14, 2026 |
| 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: