Recipient: Mexicantown Bakery, Inc United States Issuing Office: Detroit District Office United States

Department of Health and Human Services Public Health Service

Food and Drug Administration Detroit District

300 River Place

Suite 5900

Detroit, MI 48207

Telephone: 313-393-8100

FAX: 313-393-8139

WARNING LETTER

2015-DET-08

March 18, 2015

VIA UPS





Mr. Omar M. Hernandez, President

Mexicantown Bakery, Inc.

8100 Radcliffe Street

Detroit, MI 48210

Dear Mr. Hernandez:



The U.S. Food and Drug Administration (FDA) inspected your bakery manufacturing facility, located at 8100 Radcliffe Street, Detroit, MI, from October 24, 2014, through November 4, 2014. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110]. The inspection revealed that food processed at your facility is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. Additionally, Orejas and Concha manufactured by your firm are misbranded under 403 of the Act, [21 U.S.C § 343] as described in this letter. You can find the Act and FDA’s CGMP regulation for foods on the internet through links on the FDA webpage at www.fda.gov The U.S. Food and Drug Administration (FDA) inspected your bakery manufacturing facility, located at 8100 Radcliffe Street, Detroit, MI, from October 24, 2014, through November 4, 2014. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 [21 CFR Part 110].

We acknowledge your written response dated November 26, 2014, to the Form FDA-483, Inspectional Observations, issued to your firm on November 4, 2014. Your corrective actions are addressed below in relation to each of the noted violations.

The following significant violations were observed during the inspection:

1. All persons working in direct contact with food components or food-contact surfaces must use hygienic practices to the extent necessary to protect against contamination of food components or food-contact surfaces, in accordance with 21 CFR 110.10(b). Specifically, such individuals must wash hands thoroughly (and sanitize if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility before starting work and at any time when the hands may have become soiled or contaminated [21 CFR 110.10(b)(3)]. Our investigators observed employees touching unsanitized waste bins, waste in the waste bin, and packaging material and then returning to work directly with food without first washing their hands. These practices may result in the contamination of food with pathogens. The investigators also observed employees touching pecan muffins and then, without washing their hands, touching your Oreja product, which does not contain nuts. This practice may result in the contamination of Orejas with pecans. Pecans contain a known allergen.

In your response you state that “employees have been instructed to wash hands regularly” and “employees will continue to be instructed to wash hands regularly in the future.” However, you did not provide documentation that the employees were instructed or monitoring records that demonstrate that employees are washing their hands.

2. You must take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests in order to comply with 21 CFR 110.35(c). However, there were rodent excreta pellets on and around bags of food and spilled flour and a bag of sugar with a hole gnawed by rodents. Further, there was a dead rodent inside of a can on the floor of the processing room and a live insect near a pallet holding flour.

The garage type door in the southwest corner of the processing area and the loading dock door were observed to have gaps. In addition, the door leading into an unused warehouse was observed to be kept open by a cloth on the floor, and there was a gap on the wall within 1 foot from this door. In the northeast corner of the building there is an existing hole in the north wall. All of the gaps and holes may allow rodents to gain access to the facility.

In your response you indicated that you had increased the frequency of your pest extermination regimen to (b)(4). However, you did not say how you were going to prevent pests from entering the facility. Further, you did not submit documentation of that correction or of the effectiveness of the correction.

3. You must have effective hand cleaning and sanitizing preparations to comply with 21 CFR 110.37(e)(2). However, there were no paper towels or other suitable hand drying devices, trash receptacles, or readily understandable signs directing employees to wash their hands. Furthermore, a white bin was observed to be placed on one of the hand wash sinks for cleaning during processing and packaging of ready-to-eat RTE products.

In your response you state, “paper towel was placed at hand wash stations and a hand wash regimen will be implemented which will require daily inspection”. However you did not provide documentation that you had implemented these corrections. This was a repeat observation from our inspection dated May 8-17, 2012.

In addition to the above-noted CGMP violations, your Orejas bakery product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act.

Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as "major food allergens." A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either:

i. The word "Contains" followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredient, section 403(w)(1)(A) of the Act, [21 U.S.C. 343(w)(1)(A)], or

ii. The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g. “(wheat)”), except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act, 21 U.S.C. 343(w)(1)(B)].

Your Oreja bakery product food label fails to declare the following major food allergens specified by the Act:

Milk: Your Oreja bakery product is manufactured using (b)(4) bakery mix creme cake base, which contains milk.

Your Concha Blancas, Concha Yellow and Concha Pink bakery products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain a color additive which is unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379e(a)]. Section 721(a) deems a color additive to be unsafe unless its use is in conformity with the color additive listing regulation. Specifically, the listing regulation for FD&C Yellow No. 5 requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use [21 CFR 74.705(d)(2)]. Your Concha Blancas, Concha Yellow and Concha Pink bakery products are manufactured with FD&C Yellow No. 5; however, the labels for these products fail to declare FD&C Yellow No. 5 in the ingredient statements.

Your Concha Blancas, Concha Yellow and Concha Pink bakery products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because the products contain artificial coloring, but fail to bear labeling stating that fact. Specifically, your Concha Blancas, Concha Yellow and Concha Pink bakery products are manufactured with FD&C Yellow No. 5 and FD&C Yellow No. 6, and your Concha pink product is manufactured with FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 3, and FD&C Red No. 40; however, the products do not bear labels identifying the presence of these color additives using their listed names or appropriate abbreviations, as required under 21 CFR 101.22(k)(l).

We acknowledge that you performed a voluntary recall and corrected the labels. You have reported six recalls since December 22, 2010; 22 of the products recalled were recalled due to undeclared major allergens and colors. We acknowledge you recalling and correcting the labels each time; however, the recalls are repeatedly involving the same products. For example, the Concha Blancas bakery product was recalled in 2011, 2012, and again in 2014 for undeclared FD&C Yellow No. 5. Your current preventative actions appear to inadequately control your finished product labeling declarations to comply with 402(c), 403(k) and 403(w).

This letter is not intended to be an all-inclusive statement of the violations that exist at your firm or in connection with your products. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act and the Current Good Manufacturing Practice regulation [21 CFR Part 110].

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. In your response, please include documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state the time within which you will correct any remaining violations.

Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Your firm’s response should be sent to: LCDR Kelli Wilkinson, Compliance Branch, Food and Drug Administration, Detroit District Office. If you have any questions about the contents of this letter, please contact: LCDR Kelli Wilkinson, Compliance Officer, at 313-393-8120.

Sincerely,

/S/

Art Czabaniuk

District Director

Detroit District Office

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