Yoli, Inc. dba Mi Costenita 3/12/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Chicago District|
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
March 12, 2013
DELIVERED VIA UPS NEXT DAY
Mr. Jose B. Dominguez
Yoli, Inc. d/b/a Mi Costenita
7647 South Kedzie Avenue
Chicago, IL 60652
Dear Mr. Dominguez:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm located at 7647 South Kedzie Avenue, Chicago, Illinois on December 20 through December 21, 2012. During the inspection, FDA found that your facility had serious violations of the Good Manufacturing Practice (GMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations render your product adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Additionally, FDA reviewed the following product labels: Mi Costenita Pulmonaria Lungwort, Mi Costenita Cancerina, Mi Costenita Diabetina Diaurtina and Mi Costenita Yerba Del Cancer/Cancer Herb. Your Mi Costenita Yerba Del Cancer/Cancer Herb is in violation of Section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. In addition, a number of your products are misbranded within the meaning of Section 403(i) of the Act [21 U.S.C § 343(i)] because the labels fail to bear the common or usual name of the food or each ingredient as required by 21 CFR 101.4.
You may find the Code of Federal Regulations, FD&C Act, GMP Regulations, and Labeling Regulations through links on FDA’s home page at www.fda.gov
Your “Yerba Del Cancer/Cancer Herb” product is promoted for conditions that cause the product to be a drug under Section 201(g)(1)(B) of the Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claim in your product’s name that it is a “cancer herb” establishes that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Your “Yerba Del Cancer/Cancer Herb” product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under Section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the United States without prior approval from FDA as described in Section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Deviations from the GMP regulations, 21 CFR 110:
- Your plant must be constructed in such a manner that it prevents drip or condensate from fixtures, ducts and pipes from contaminating food, food-contact surfaces, or food-packaging materials structural design in order to comply with 21 CFR 110.20(b)(4). However, condensate was dripping on top of and inside of a blender while you were blending flavoring.
- You must clean and sanitize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging material in order to comply with 21 CFR 110.35(a). However your firm used (b)(4) to clean peanut residue from the packaging equipment which (b)(4) the peanut dust. Open bags of peach rings were present in the packaging room and were exposed to the (b)(4) peanut dust. Peanuts are known allergens and peanut-allergic individuals may be sensitive to minute quantities of peanuts.
In our document, Good Manufacturing Practices (GMPs) for the 21st Century - August 9, 2004, FDA recommends controls such as separation of production lines, use of physical detachments and lockouts, use of staging areas, routine maintenance of manufacturing equipment, and properly conducted, unbiased, third party audit of GMPs to control allergen cross-contact.
Deviations from the food labeling requirements:
- Your “Yerba Del Cancer/Cancer Herb” and “Diabetina” products are misbranded within the meaning of Section 403(i) of the Act [21 U.S.C § 343(i)] because the labels fail to bear the common or usual name of the food or each ingredient as required by 21 CFR 101.4.
• Your “Yerba Del Cancer/Cancer Herb” product ingredient statement states “cancer herb” rather than the specific type of herb contained in the product. According to 21 CFR 101.4(b), the name of an ingredient shall be a specific name and not a collective (generic) name.
• Your “Diabetina” product label ingredient statement states “Diaurtina.” Diaurtina is not a common or usual name of an ingredient.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction, civil money penalties, or misdemeanor prosecution.
Please notify this office in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken to correct the noted violations and to prevent these violations or other similar violations from occurring again. Include documentation, including photographs, other materials, of all of the corrective actions you have taken to date. If your planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections. Your firm’s response should be comprehensive and address all violation(s) included in this Warning Letter.
Your response should be sent to: Rosemary Sexton, Compliance Officer, U.S. Food and Drug Administration, 550 W. Jackson Blvd., 15th Floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS case # 392314). If you have any questions about the content of this letter, please contact Ms. Sexton at 312-596-4225 or via email at firstname.lastname@example.org.
Scott J. MacIntire