FDA WARNING_LETTER - Yoli, Inc. dba Mi Costenita - December 21, 2012

The FDA conducted an inspection of Yoli, Inc. dba Mi Costenita from December 20-21, 2012, identifying serious violations of Good Manufacturing Practice (GMP) regulations (21 CFR Part 110), rendering products adulterated. Additionally, product labels were reviewed, revealing drug and misbranding violations.

Specific GMP violations included: * Condensate dripping into a blender during flavoring, violating 21 CFR 110.20(b)(4) regarding facility construction to prevent contamination. * Improper cleaning of peanut residue from packaging equipment using (b)(4), which dispersed peanut dust, exposing open bags of peach rings to a known allergen. This violates 21 CFR 110.35(a) concerning cleaning and sanitizing to prevent contamination.

The "Mi Costenita Yerba Del Cancer/Cancer Herb" product was cited as an unapproved new drug under Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)] because its name implies therapeutic use for cancer, making it a drug under Section 201(g)(1)(B) [21 U.S.C. § 321(g)(1)(B)] and a "new drug" under Section 201(p) [21 U.S.C