FDA WARNING_LETTER - Nanomateriales Químicos Avanzados, S.A. de C.V. - September 10, 2020

The FDA issued a Warning Letter to Nanomateriales Químicos Avanzados, S.A. de C.V. (formerly Nanomateriales S.A. de C.V.) on September 15, 2021, following an import attempt of their ZANILAST + Gel, 25kg product, which was detained and refused admission. FDA testing revealed the product, labeled to contain 65% ethanol, actually contained 0.0% ethanol and 41% 1-propanol, an unapproved and dangerous active ingredient, rendering it adulterated under section 501(d)(2) of the FD&C Act.

The letter also cited significant Current Good Manufacturing Practice (CGMP) violations (21 CFR parts 210 and 211) based on records provided by the firm. These include failure to conduct adequate finished drug product testing (21 CFR 211.165(a)), specifically identity and strength of active ingredients, and failure to verify the identity of each component and validate supplier test analyses (21 CFR 211.84(d)(1) and (2)). The firm accepted supplier Certificates of Analysis (COAs) without sufficient verification. Furthermore, the Quality Control Unit (QU) lacked adequate oversight, approving product formula changes without evaluating impact and releasing mislabeled batches containing 1-propanol (21 CFR