# 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/e5b41091-516c-4aa6-96d4-8d118c9cdedd

> 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: FDA District Office — Denver, Colorado
- Summary: Island Kinetics, Inc. d.b.a. CoValence Laboratories, a drug manufacturer in Chandler, AZ, received a Form 483 with multiple repeat observations during an FDA inspection. The firm was cited for significant failures in establishing adequate production and process controls, thoroughly investigating discrepancies and out-of-specification results, and properly maintaining and cleaning equipment. These deficiencies indicate a lack of control over manufacturing processes and potential risks to the quality and purity of their OTC drug products.

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## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)
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Company: https://www.keypedia.com/companies/island-kinetics-inc-dba-covalence-laboratories/1e7113af-8d57-4d48-a0f4-5bfb0ba7060e

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0