PRITAM INTERNATIONAL PRIVATE LIMITED – FDA Warning Letter, Jun 6, 2026

The FDA issued a warning letter to Pritam International Private Limited on October 27, 2026, following an inspection of its Haridwar, India facility in June 2026 and a prior records review. The document outlines severe violations of the Federal Food, Drug, and Cosmetic Act and Current Good Manufacturing Practice (CGMP) regulations, which have led to the facility’s drug products being classified as adulterated. Key issues include the use of a prohibited color additive (CI 14720) in toothpaste marketed to children, the falsification of microbiological test results, and a critical failure to test high-risk ingredients like sorbitol for lethal contaminants such as diethylene glycol (DEG) and ethylene glycol (EG). Furthermore, the company’s quality unit failed to provide adequate oversight, evidenced by a poorly maintained water system and unreliable laboratory data. The FDA acknowledges that the firm initiated a voluntary product recall in September 2026 and placed the facility on an import alert. To remediate these issues, the company must hire independent experts to conduct a comprehensive audit of their data integrity and manufacturing systems. Pritam International is required to provide a detailed corrective action plan within 15 business days, including risk assessments for distributed products and a commitment to robust raw material testing. Failure to resolve these violations may result in the continued refusal of their products into the United States.