Grimann S.A. de C.V. Warning Letter Details

Summary

Grimann S.A. de C.V. was cited for failure to comply with drug registration and listing requirements for Derofen Miel (NDC 81660-435), a cough/cold medication. The company submitted contradictory information between the product's physical labeling and its electronic listing file in FDA's Drug Registration and Listing System, most critically listing propylene glycol as the active ingredient in the electronic file while the actual carton label identified dextromethorphan and guaifenesin as active ingredients—a direct violation of Section 510(j) of the FD&C Act and 21 CFR Part 207. These deficiencies had been previously identified in an October 2021 deficiency letter, and the company's failure to correct them resulted in data removal of the product from FDA's Online NDC Directory in December 2021.