FDA WARNING_LETTER - GC America, Inc. - November 07, 2025

The FDA issued a warning letter to GC America, Inc. following an inspection of its manufacturing facility in Alsip, Illinois, conducted between November 3 and 7, 2025. The inspection identified several critical failures to meet federal manufacturing standards for over-the-counter drug products, leading the agency to classify these products as adulterated under the Federal Food, Drug, and Cosmetic Act.

The primary violations involve inadequate testing of raw materials and components. Specifically, GC America failed to properly test the water used in its manufacturing process for chemical and microbial quality. More concerningly, the company did not conduct mandatory identity testing on high-risk ingredients to ensure they were free from hazardous contaminants like diethylene glycol, which has historically caused lethal poisoning. Additionally, the company lacked a valid stability testing program to prove its products remain safe and effective until their expiration dates. The FDA also noted significant deficiencies in the quality control unit, including poor oversight of electronic data, unsecured passwords, and a failure to perform required annual product reviews since 2018.

To address these issues, GC America must conduct a comprehensive risk assessment of its products currently on the market and implement a remediated stability and material testing program. The FDA strongly recommends the company hire a qualified consultant to assist in correcting these systemic failures. A formal response detailing the company’s corrective actions and preventive measures is required within 15 working days.