| Public Health Service Food and Drug Administration |
| 466 Fernandez Juncos Avenue San Juan, Puerto Rico, 00901 Compliance Branch Telephone: 787-474-9500 FAX: 787-729-6658 |
Department of Health and Human ServicesSeptember 30, 2011
WARNING LETTER
11-SJN-WL-16
OVERNIGHT MAIL
Returned Receipt Requested
Mrs. Olga Aymat Chacon, President
Repostería Aymat, Inc.
225 Calle Eleonor Roosevelt
San Juan, PR 00918-3010
Dear Mrs. Aymat:
The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 225 Calle Eleanor Roosevelt, San Juan PR, from May 4 – 5 and 12, 2011. This inspection found that you have serious violations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Food (CGMP) regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the products prepared or stored at your facility to be 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health.
In addition, FDA collected product labels and samples of your pastry products during the inspection of your facility. Based on our review of the labels, we have determined that your Donas Glaceadas Aymat products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in Title 21, Code of Federal Regulations (CFR), Part 101 [21 CFR Part 101]. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
Your significant violations are as follow:
1. Your firm failed to maintain equipment, utensils, in an acceptable condition through appropriate cleaning and sanitizing in accordance with 21 CFR 110.80(b)(1). For example:
• On 05/05/2011, our Investigators observed rust on the impeller of your industrial mixer used to prepare donut glaze. The Investigators also determined that you do neither use cleaning nor sanitation agents to clean the mixer due to its geometric configuration. The Investigators further determined that you only use hot water to remove food residues from the mixer at the conclusion of your daily manufacturing operations.
• On 05/05/2011, our Investigators observed that bins used during manufacturing operations were not cleaned showing old food residues.
• Trays utilized inside the proofing cabinet showed residues of dark grease, dirt and encrusted food. The Investigators observed that four of these trays were hanging from a dirty shelf on the wall of your production area. The Investigators also determined that trays are never dismantled for cleaning and they are only wiped with a wet rag from time to time because they do not need to be cleaned due to the high temperatures inside the proofer.
• On 05/05/2011, our Investigators observed that two cooling fans used to cool the fried and glazed donuts located throughout the conveyor line were covered with dust. These fans were blowing air directly over unprotected finished donuts.
2. Your firm’s employee failed to wash hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and any other time when the hands may have become soiled or contaminated in accordance with 21 CFR 110.10(b)(3). Specifically, an employee touched food dough with his bare hands without washing and or sanitizing first. This same employee was observed to have touched tools, utensils and water used to moisten equipment parts prior to touching the food dough.
3. Your firm’s employee failed to maintain gloves in food handling in an intact, clean and sanitary condition in accordance with 21 CFR 110.10(b)(5). Specifically, the Investigators observed that one of your employees touched his forehead, clothes, and different equipment parts with his gloves on before handling finished product. This particular employee did not change, wash or sanitize his gloves prior to touching the previously mentioned items.
4. Your firm’s employees failed to wear beard covers where appropriate in accordance with 21 CFR 110.10(b)(6). For instance, on 05/05/2011, the Investigators observed that three employees working during the donuts packaging operations failed to cover their mustaches and beard.
Misbranding
5. Your Donas Glaceadas Aymat brand product (glazed donuts) is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label for this product fails to declare the known major food allergens, soy and wheat, as specified by the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as “major food allergens” 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. 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:
• The word “Contains,” followed by the name of the food source from which the major food allergen is derived, 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
• 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 Donas Glaceadas Aymat brand product (glazed donuts) product formulation reveals that margarine and High Gluten Spring Wheat Flour are used in the manufacturing process. Margarine contains soy lecithin as a sub-ingredient and the flour is prepared by grinding and bolting cleaned wheat. Soy and wheat are major food allergens; however your finished product label fails to declare the presence of soy and wheat.
Further guidance and information on food allergens can be accessed on FDA’s website at:
http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
6. Your Donas Glaceadas Aymat brand product (glazed donuts) is misbranded within the meaning of section 403(i)(2) [21 U.S.C. § 343(i)(2)] of the Act in that your label fails to declare all of the ingredients used by your firm in the production of these donuts in accordance with 21 CFR 101.4. For example:
• The affidavit collected during the inspection states that dough softener, yeast, and baking powder are used in the manufacture of your donuts, however based on the ingredient statement the dough softener, yeast, and baking powder are not declared on your product label in accordance with 21 CFR 101.4(a)(1).
• Your product label declares “manteca vegetal” (vegetable fat or lard) however you fail to identify the individual fat and/or oil ingredient by its specific common or usual name (e.g., soybean and cottonseed oil) in accordance with 21 CFR 101.4(b)(14).
The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient. Under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
• We also note that your donut products declare “Harina Enriquecida” (enriched flour) which makes reference to the High Gluten Spring Wheat Flour. Enriched flour is a food for which a standard of identity has been established in Section 21 CFR 137.165 and contains wheat flour, niacin, iron, thiamin mononitrate, riboflavin, and folic acid. These components are not listed on the ingredient statement of your Donas Glaceadas Aymat brand product. If your glazed donut products contain enriched flour, you must declare all of the ingredients in the enriched flour.
7. Your Donas Glaceadas Aymat brand product (glazed donuts) is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the label fails to bear nutrition labeling information in accordance with 21 CFR 101.9. Specifically,
• Your Donas Glaceadas Aymat brand product label fails to bear a statement of the number of grams of Trans Fat in accordance with 21 CFR 101.9(c)(2)(ii);
• Your Donas Glaceadas Aymat brand product label fails to declare the % Daily Values in the Nutrition Facts box as required by 21CFR 101.9(d)(7)(i) and (ii);
• Your Nutrition Facts panel on the 16oz Donas Glaceadas Aymat brand product appears to be on the bottom of the box, which is not acceptable; rather it must be located on the information panel in accordance with [21 CFR 101.2(d)(1)].
Your firm may be eligible for certain exemptions from nutrition labeling requirements, such as the Small Business Nutrition Labeling Exemption. We recommend you review the nutrition labeling exemptions in 21 CFR 101.9(j)(18), or see :
http://www.fda.gov/Food/LabelingNutrition/FoodLabelingGuidanceRegulatoryInformation/SmallBusinessNutritionLabelingExemption/default.htm, for information on filing for an annual exemption. The application may be submitted online at:
https://info1.cfsan.fda.gov/nle/client/login.cfm.
This letter is not meant to be an all-inclusive list of the violations at your manufacturing facility or in your product labeling. It is your responsibility to ensure that your products comply with all of the laws and regulations enforced by FDA, including the CGMP regulations (21 CFR Part 110) and the Food Labeling regulations (21 CFR Part 101).
You should take prompt action to correct the violations described above and prevent future recurrence. Failure to correct these violations may result in further enforcement action being initiated by the FDA without prior notice. For instance, the Act provides for the seizure of violative products, the assessment of civil money penalties, and the injunction of a manufacturer or distributor of violative food products.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Additionally, your response should include other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
FDA acknowledges receipt of your response letter received on June 1, 2011, which identifies the corrective actions you have taken or plan to take in response to the Inspectional Observations reported to you on the form FDA-483 issued on May 12, 2011. Our review finds that most of the proposed and corrective actions taken appear to be adequate. However, because you provided no photographs or other evidence to assist FDA in determining the adequacy your corrections, FDA cannot fully evaluate those corrections based solely on your written response. The corrections will be verified and evaluated during the next inspection of your facility.
Further, FDA still has concerns about your current employee practices. Although your response letter proposed that formal CGMP training will be provided to all of your employees as a preventive action, the letter failed to specify when the training will be delivered.
We also point out, your 16 ounce and 8 ounce donut labels declare information in both Spanish and English, however, the ingredient statement, net weight, and manufacturers address on these labels do not appear in both languages in accordance with 21 CFR 101.15(c).
Please send your written reply to the Food and Drug Administration, attention: Rafael Nevarez, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Nevárez at (787) 474-9545.
Sincerely,
/s/
Maridalia Torres
District Director
San Juan District
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