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

The FDA inspected the manufacturing facility of Island Kinetics, Inc. (d.b.a. CoValence Laboratories) in Chandler, Arizona, from January 14 to 23, 2026. The inspection revealed significant failures to follow Current Good Manufacturing Practice (CGMP) regulations and violations of the Federal Food, Drug, and Cosmetic Act. Primary issues included a lack of manufacturing process validation, meaning the company could not prove their products were consistently produced to quality standards. Additionally, the firm failed to validate equipment cleaning procedures to prevent cross-contamination and operated an unvalidated water system that showed signs of microbial contamination. The company also failed to properly investigate laboratory test failures, such as products not meeting thickness specifications.

Furthermore, the FDA identified several acne treatment products—including TreeActiv Cystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment—as unapproved new drugs and misbranded products. These items made medical claims regarding "cystic" and "hormonal" acne that exceed the legal limits for over-the-counter sales without specific FDA approval. Because many of these issues are repeat violations from inspections in 2016 and 2020, the FDA recommends the company hire an independent consultant to help achieve compliance. CoValence Laboratories must provide a detailed remediation plan, conduct risk assessments for products already distributed to the public, and submit a formal response within 15 working days to avoid further legal action, such as product seizures or manufacturing injunctions.