TSP Solutions Pte. Ltd. – FDA Warning Letter, Sep 9, 2025

The FDA issued a warning letter to TSP Solutions Pte. Ltd., a Singapore-based manufacturer of over-the-counter sunscreen products, following a records review initiated in September 2025. The letter, dated October 22, 2026, outlines significant violations of Current Good Manufacturing Practice (CGMP) regulations as defined under the Federal Food, Drug, and Cosmetic Act. The FDA determined that the firm"s drug products are adulterated due to these manufacturing deficiencies.

Key violations include the company’s failure to perform adequate laboratory testing on finished drug products to confirm the identity and strength of active ingredients before distribution. Furthermore, the firm failed to conduct required microbiological testing. The inspection also revealed that the company did not verify the identity of incoming raw materials, instead relying solely on unvalidated supplier certificates. Finally, the FDA found that the company’s quality unit failed to provide sufficient oversight of manufacturing processes, production controls, and stability programs.

As a result of these findings, the FDA placed the firm’s products on an import alert in August 2026. To address these violations, TSP Solutions must hire a qualified independent consultant to conduct a comprehensive audit of its operations. The firm is also required to submit a detailed action plan for testing retain samples of products currently in the U.S. market, establish rigorous supplier qualification procedures, and remediate its quality management system. Failure to resolve these issues may lead to continued import refusal and the withholding of future product approvals.