FDA Drugs· FDA·· 7 hours agoScore50
TSP Solutions Pte. Ltd. - 735071 - 10/22/2026
In brief
FDA issued a warning letter to TSP Solutions Pte. Ltd. on October 22, 2026, citing significant CGMP violations: the OTC drug manufacturer failed to complete finished-product testing before release and incoming material identity testing, making its products adulterated under section 501(a)(2)(B) of the FD&C Act. FDA requires the firm to test retain samples of all batches distributed to the United States and still within expiry, notify customers and recall any products found out of specification; inadequate remediation may lead to regulatory action.
Source: FDA Drugs · fda.gov