FDA WARNING_LETTER - kdc/one Chatsworth, Inc. - April 03, 2026

The FDA issued a warning letter to kdc/one Chatsworth, Inc. following an inspection of its drug manufacturing facility in Chatsworth, California, conducted from March 31 to April 3, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, resulting in the company’s over-the-counter (OTC) drug products being classified as adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues identified include the failure to perform adequate laboratory testing on finished products prior to distribution. Specifically, the firm did not test for benzene—a known carcinogen—despite using ingredients with known degradation pathways. The FDA also noted that the company failed to investigate a related product recall in Canada or assess the risks to U.S. consumers. Additionally, the firm failed to thoroughly investigate out-of-specification results regarding product viscosity and stored drug products in warehouse conditions that significantly exceeded labeled temperature requirements, further risking chemical degradation.

To remediate these violations, the FDA requires the company to engage an independent CGMP consultant to oversee corrective actions. Required steps include providing a comprehensive risk assessment for benzene contamination in current market batches, performing chemical testing on retain samples, and establishing a robust stability testing program. The firm must also implement stricter Quality Unit oversight and environmental controls for storage areas to ensure ongoing compliance with federal safety standards.