• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Pastry Food Products, Inc. 10/24/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

San Juan District
Compliance Branch
466 Fernandez Juncos Avenue
San Juan Puerto Rico 00901-3223
Telephone: 787-474-9500
FAX: 787-729-6658 

OCT-24-2011


12-SJN-WL-02


VIA OVERNIGHT MAIL


Mr. Pedro A. Santos, Owner
Pastry Food Products, Inc.
P.O. Box 29884
San Juan, PR 00929


Dear Mr. Santos:


The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at Eider 932 Street Country Club Extension, San Juan PR, 00929, on 06/07-15/2011, (all dates not inclusive). The inspection revealed that you have serious violations of the Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Food (CGMP) regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations caused 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 unsanitary 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 the turnover dough (round products), during the inspection of your facility. Our review of the labels found that your Trigal “Empanadillas de Pizza”, Trigal “Empanadillas Sabor a Carne”, Trigal “Pastelillos Coctel de Pizza” and Trigal “Plantillas Coctel para Pastelillos y Tacos” products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] and the implementing regulations at 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.


Our current inspection documented the following deficiencies:


CGMP Violations


1. Your firm failed to take all reasonable precautions to ensure that production procedures does not contribute to contamination from any source in accordance with 21 CFR 110.80.
For example, on 06/07-08/2011, our Investigator observed dough coming in contact with an employee's soiled apron and with the floor during the turnover (b)(4) manufacturing process.


2. Your firm's employee failed to wear where appropriate in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints in accordance with 21 CFR 110.10(b)(6). For example, an employee failed to wear a beard cover while handling turnover dough during the (b)(4)

 

3. Your firm failed to provide running water at a suitable temperature for the equipment cleaning, utensils, food-packaging materials, and employee sanitary facilities in accordance with 21 CFR 110.37(a). For instance, on 06/07-08/2011 our Investigator observed that the sinks located at the employee men's & women's restrooms and hand washing sink located at the manufacturing area failed to have hot water. Additionally, no hot water was available at the three compartment sink utilized for cleaning utensils located at the manufacturing area.


4. Your firm failed to provide safety-type lighting fixtures suspended over exposed food in accordance with 21 CFR 110.20(b)(5). Specifically, on 06/07-08/2011, our Investigator observed that fluorescent lamps located in the manufacturing area failed to have protective shields to prevent food contamination. For example, the following areas where foods are manufactured had fluorescent lamps that lacked protective fixtures:


a. Manufacturing area were cheese balls, corn fritters, and pizza filled turnovers were manufactured.


b. Kneading machine processing turnover dough and inside a commercial mixer where turnover dough was being processed.


c. Stainless steel table used to handle cornmeal dough in the cooking area.


5. Your firm failed to transport finished food under conditions that would protect against microbial contamination in accordance with 21 CFR 110.93. Specifically, the product labels specify that products must be kept refrigerated; however, on 06/08/2011 you admitted that finished products are distributed in a van that lacks refrigeration system. Transportation times of the finished food products to customers range from 30 minutes to 1.5 hours at non-refrigerated temperatures.


Labeling Violations


6. Your Trigal "Pastelillos Coctel de Pizza" 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 allergen 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, is printed immediately after or adjacent to the list of ingredients, 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 Trigal "Pastelillos Coctel de Pizza" product formulation reveals that mozzarella cheese (filling) is used in the manufacturing process, which contains milk. However, your finished product label fails to declare the presence of the major food allergen, milk.


Further guidance and information on food allergens can be accessed on FDA's website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.


7. Your Trigal "Pastelillos Coctel de Pizza", "Empanadillas Sabor a Came" and "Plantillas Coctel para Pastelillos y Tacos" products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that they are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient in the product, or because the ingredient statement fails to list the component ingredients of all of their ingredients, as required by 21 CFR 101.4(b)(2). Specifically:


• Your Trigal "Pastelillos Coctel de Pizza" and "Empanadillas Sabor a Carne" product labels fail to properly declare the common or usual name of several ingredients as required by 21 CFR 101.4(a)(1). Your list of ingredients for the Trigal "Pastelillos Coctel de Pizza" and "Empanadillas Sabor a Came" products indicate that "sofrito" is used; however, all of the ingredients in this sauce base are not declared on the product label.
 

• Your Trigal "Plantillas Coctel para Pastelillos y Tacos" product label fails to properly declare the common or usual name of several ingredients as required by 21 CFR 101.4(a)(1). Your product formulation for the "Plantillas Coctel para Pastelillos Tacos" product includes the ingredient (b)(4) however all of the ingredients in this all purpose shortening are not declared on the product label.


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; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.


8. Your Trigal "Pastelillos Coctel de Pizza" and "Plantillas Coctel para Pastelillos y Tacos" products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined within 21 CFR 101.9. Specifically,


• The Calories for your Trigal "Pastelillos Coctel de Pizza" and "Plantillas Coctel para Pastelillos y Tacos" products are not expressed to the nearest 5 cal increment [21 CFR § 101.9(c)(1)];


• The Calories from Fat for your Trigal "Pastelillos Coctel de Pizza" contains less than 50 cal per serving, as a result the content shall be expressed to the nearest 5 cal increment [21 CFR § 101.9(c)(1)(ii)];


• The Total Fat for your Trigal "Plantillas Coctel para Pastelillos y Tacos" product is not expressed to the nearest 0.5 g increment [21 CFR § 101.9(c)(2)];


• The Cholesterol for your Trigal "Pastelillos Coctel de Pizza" contains less than 2 mg per serving, as a result the content shall be expressed as zero [21 CFR § 101.9(c)(3)];


• The Sodium for your Trigal "Plantillas Coctel para Pastelillos y Tacos" product is not expressed to the nearest 10 mg increment [21 CFR § 101.9(c)(4)];


• The Potassium for your Trigal "Pastelillos Coctel de Pizza" product is not expressed to the nearest 5 mg increment [21 CFR § 101.9(c)(5)];


• The Dietary Fiber for your Trigal "Plantillas Coctel para Pastelillos y Tacos" contains less than 0.5 g per serving, as a result the content shall be expressed as zero [21 CFR § 101.9(c)(6)(i)];


• Iron in your "Plantillas Coctel para Pastelillos y Tacos" is not expressed to the nearest 2-percent increment equal to the 10-percent level as required [21 CFR 101.9(c)(8)(iii)].


We further note, that according to the raw material label, the flour ingredient used in your products is "Enriched Bleached Flour." The flour ingredient declared on the product labels is simply "flour." Flour and Enriched Bleached Flour are two different foods by regulation as defined within section 21 CPR 137.105 and 137.165.


For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.


This letter is not meant to be an all-inclusive list of the violations at the 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 the receipt of this letter. The response should outline the specific steps that you are taking to correct these violations. Additionally, the response should include other useful information that would assist us in evaluating the 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.


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 there are any questions regarding any issue in this letter, please contact Mr. Nevarez at (787) 474-9545.


Sincerely,
/S/

Maridalia Torres
District Director
San Juan District