FDA WARNING_LETTER - Grimann S.A. de C.V. - May 31, 2022

On May 23, 2022, the FDA issued a Warning Letter (WL 2257) to Ms. Gonzalez regarding Derofen Miel, NDC 81660-435. The FDA's review of the firm's drug listing information in the eDRLS revealed contradictory information between the product's labeling and its electronic listing file. This constitutes a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The firm had previously received a drug listing deficiency letter on October 18, 2021, and a data removal email notification on December 2, 2021, which informed them of the product's data removal from the FDA's Online NDC Directory due to continued deficiencies.

The identified deficiencies in the listing for Derofen Miel, NDC 81660-435, indicate that the firm has not fulfilled its listing obligations under Section 510(j) of the FD&C Act, which is a prohibited act under Section 301(p). Additionally, the failure to properly list the drug renders it misbranded under Section 502(o) of the FD&C Act, violating Section 301(a).

The FDA emphasizes that complete, accurate, and up-to-date registration and listing information is crucial for patient safety, drug establishment inspections, supply chain security,