Botanicals Internacional S.A. de C.V. Warning Letter Details

Summary

Botanicals Internacional S.A. de C.V. was warned for manufacturing inatek HAND SANITIZER, an unapproved antiseptic hand sanitizer drug product that was found to be adulterated due to substance substitution and was misbranded under multiple sections of the Food, Drug, and Cosmetic Act. FDA laboratory testing of a batch detained at the U.S. border revealed that the product's quality assurance systems failed to comply with Current Good Manufacturing Practice (CGMP) requirements, as evidenced by the substitution of materials in the formulation. The product was prohibited from introduction or delivery into interstate commerce under sections 301(d) and (a) of the FD&C Act, and the firm's recent registration as a human drug manufacturer made these violations particularly significant at the point of their first regulatory scrutiny.