# FDA 483 - Island Kinetics, Inc. d.b.a. CoValence Laboratories - January 23, 2026

Source: https://www.keypedia.com/records/483/island-kinetics-inc-dba-covalence-laboratories/5bec588f-21b3-4043-ba6a-38bc21e82584

> FDA 483 for Island Kinetics, Inc. d.b.a. CoValence Laboratories on January 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Island Kinetics, Inc. d.b.a. CoValence Laboratories
- Inspection Date: 2026-01-23
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Island Kinetics, Inc. d.b.a. CoValence Laboratories in Chandler, AZ, was cited for significant repeat violations during an FDA inspection. The firm failed to establish adequate production and process controls, thoroughly investigate discrepancies and out-of-specification results, and properly maintain and qualify equipment. These issues indicate a systemic lack of control over manufacturing processes and quality systems, posing a risk to drug product quality and purity.

## Related Documents

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- [483 - 2026-01-23](https://www.keypedia.com/records/483/island-kinetics-inc-dba-covalence-laboratories/e5b41091-516c-4aa6-96d4-8d118c9cdedd)
- [WARNING_LETTER - 2026-01-23](https://www.keypedia.com/records/warning_letter/island-kinetics-inc-dba-covalence-laboratories/ea0a1657-eb07-4f39-9c35-43d1cfc2d923)

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/island-kinetics-inc-dba-covalence-laboratories/1e7113af-8d57-4d48-a0f4-5bfb0ba7060e

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face