FDA WARNING_LETTER - Laboratorios Dr. Collado S.A. - August 01, 2025

The FDA issued a Warning Letter to Laboratorios Dr. Collado S.A. on June 2, 2026, following a review of records initiated in August 2025. The facility, based in the Dominican Republic, was found to have significant violations of Current Good Manufacturing Practice (CGMP) regulations for over-the-counter drug products. The main violations center on the company"s failure to establish adequate laboratory controls and specifications for talc, a component used in their drug products. The FDA highlighted the specific risk of asbestos contamination in talc, noting that the company lacked testing procedures to ensure the absence of this carcinogen. Furthermore, the methods used by the company’s contract laboratory were deemed insufficient to detect asbestos fibers. The Quality Unit was also cited for failing to provide proper oversight, as they approved raw materials without ensuring they met established safety and purity standards. Under the Federal Food, Drug, and Cosmetic Act, these deficiencies mean the products are considered adulterated. The FDA has mandated several corrective actions, including a full risk assessment of all products currently on the market that contain talc, testing of retained samples for asbestos, and a comprehensive remediation plan to strengthen the Quality Unit"s authority. While the company indicated they have ceased manufacturing talc-containing products, the FDA requires written notification and documentation of validated testing procedures before they may resume production. Failure to address these issues could result in the FDA blocking the company’s products from entering the United States.