| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human Services
WARNING LETTER
VIA UPS OVERNIGHT
SIGNATURE REQUIRED
June 17, 2011
Our Reference Number: 3004256842
Javier Ramierz, CEO
La Fiesta Food Products, Inc.
940 McLaughlin Avenue
San Jose, CA 95122
Dear Mr. Ramierz:
We inspected your seafood repackaging facility located at 940 McLaughlin Ave., San Jose, CA 95122 between February 2 and 24, 2011. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products 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). Accordingly, your dried shrimp products, including but not limited to, shredded shrimp and whole shrimp, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that, at a minimum, are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption."
However, your firm does not have a HACCP plan for your dried shrimp seafood products to control the food safety hazard of undeclared food intolerance substances (sulfites). During the inspection, our investigators collected a sample of dried shredded shrimp from bulk cartons in which your firm repacks into several retail sized packages. FDA laboratory analysis of that sample of shredded shrimp was found to contain between 651 to 685 ppm of sulfites.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm has not maintained any records of the monitoring of sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing and hand sanitizing, protection of food, food packaging material, and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals, control of employee health conditions, and exclusion of pests.
Misbranding
During the inspection of your facility, we also collected labels of your food products for review. Based on our review, we have determined that your Mi Pueblo brands Shredded Shrimp (Camaron Molido) and Whole Body Shrimp (Camaron Entero) and La Fiesta brands Shredded Shrimp, Large Whole Shrimp, and Fancy Whole Shrimp products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 [21 CFR Part 101].
3. Your retail Mi Pueblo and La Fiesta brand Shrimp products (whole body, large body, fancy, and shredded) are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients but the labels fail to declare the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1). Specifically,
- The A.L.C. Brand bulk containers for your Mi Pueblo Whole Body Shrimp, La Fiesta brands Large Body Shrimp, and Fancy Whole Shrimp products indicates that salt is added; however this ingredient is not declared on your finished product label
- In addition, Sample 677448, an official sample of shredded shrimp collected from bulk cartons at your firm was analyzed for the presence of sulfites and the results of the analysis by San Francisco Laboratory found that the sample contained a range between 651 to 685 ppm of sulfites. Your firm repackages this product into retail units for sale, however the finished product labeling of this product does not declare sulfites. Certain consumers having severe sensitivity or allergies to sulfite run the risk of allergic reactions if they consume this product.
We acknowledge that on April 8, 2011, you initiated a voluntary recall of all your Dried Shredded Shrimp (Camaron Molido) products due to undeclared sulfites. Based on your Press Release, it states that you will have new labels stating “Allergen Information: Contains Sulfites.” We note that sulfites are not considered a major allergen and must not be declared as part of an allergen "Contains" statement. The actual sulfiting agent must be declared (e.g. Sodium Metabisulfite or Sulfur Dioxide) in the product’s ingredient statement to be in compliance with 21 CFR 101.4(a)(1).
4. Your retail Mi Pueblo brands Shredded Shrimp and Whole Body Shrimp products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that their labeling does not contain the name and place of business of the manufacturer, packer, or distributor. According to 21 CFR 101.5(a), the label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
5. Your retail Mi Pueblo brands Shredded Shrimp and Whole Body Shrimp and La Fiesta brands Shredded Shrimp, Large Whole Shrimp, and Fancy Whole Shrimp products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that your products fail to provide nutrition facts information in accordance with 21 CFR 101.9.
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. We have no record of your firm having filed a Small Business Nutrition Labeling Exemption Notice.
6. Your Mi Pueblo and La Fiesta brand shrimp products are misbranded with the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)], because your product labels contain information in two languages but do not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
The above violations are not meant to be an all-inclusive list of deficiencies in your plant and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. We may take further action if you do not promptly correct these violations. Failure to do so may result in regulatory action without further notice, including but not limited to, seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, labeling, 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 when you will correct any remaining violations.
Please send your reply to the attention:
Darlene Almogela
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
If you have any questions regarding any issues in this letter, please contact Ms. Almogela at 510-337-6769 or Juliane Jung-Lau,Compliance Officer, at (510) 337-6793.
Sincerely,
/S/
Barbara J. Cassens
District Director
cc: Francisco J. Lopez, General Manager
La Fiesta Food Products, Inc.
940 McLaughlin Avenue
San Jose, CA 95122
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