Nanomateriales Químicos Avanzados, S.A. de C.V. Warning Letter Details

Summary

Nanomateriales Químicos Avanzados, S.A. de C.V., a Mexican manufacturer of over-the-counter hand sanitizer products, was cited for manufacturing adulterated drugs in which substances were wholly or partially substituted, as demonstrated by FDA laboratory testing of a ZANILAST + Gel batch detained at the U.S. border. The company failed to maintain current good manufacturing practice (CGMP) standards for finished pharmaceuticals, with deficiencies identified in manufacturing methods, facility controls, and quality assurance processes that did not conform to 21 CFR parts 210 and 211.