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

Source: https://www.keypedia.com/records/warning_letter/yoli-inc-dba-mi-costenita/16d19725-e3c1-4a59-a4ff-981340755b92

> FDA WARNING_LETTER for Yoli, Inc. dba Mi Costenita on December 21, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Yoli, Inc. dba Mi Costenita
- Inspection Date: 2012-12-21
- Product Type: Food
- Office Name: Chicago District Office
- Summary: 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

## Related Officers

- [Scott J. Macintire](https://www.keypedia.com/people/scott-j-macintire/ca3dc0d0-ffd3-4d61-bd98-56aa7d8b15af)

Company: https://www.keypedia.com/companies/yoli-inc-dba-mi-costenita/8d098870-62f8-4d7d-bbb4-96254802ed2e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669