Inspections, Compliance, Enforcement, and Criminal Investigations
Rojas, Inc. 11/15/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
RETURN RECEIPT REQUESTED
Date: November 15, 2011
Heberto Rojas, Jr., President and Owner
2843 Whittier Boulevard
Los Angeles, CA 90023-1526
Dear Mr. Rojas:
The U.S. Food and Drug Administration (FDA) inspected your seafood repackaging facility located at 2843 Whittier Blvd., Los Angeles, California between August 9 and 12, 2011. Our investigation 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, ground shrimp, whole peeled shrimp, and whole body shrimp are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
During the inspection of your facility, we also collected labels of your finished retail packages for review. Based on our review, we have determined that your (b)(4) Ground Shrimp (Camaron Molido), Peeled Shrimp (Camaron Pelado) and Whole Shrimp (Camaron Entero) are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and the applicable regulations in Title 21, Code of Federal Regulations, Pat'! 101 [21 CFR Part 101]. You may find the Act and its implementing regulations through links on FDA's website at http://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). On August 15, 2011, our investigator collected a sample of dried ground shrimp in finished retail packages which are repacked from dried bulk shrimp. FDA laboratory analysis of that sample of ground shrimp was found to contain between 352 to 375 parts per million ("ppm") of sulfites. In addition, a second sample consisting of finished retail packages of dried peeled shrimp, which are repacked from dried bulk shrimp was found by FDA analysis to contain between 142 and 155 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.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
3. Your retail (b)(4) Shrimp products (whole body, whole peeled, and ground) are the 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 (b)(4) bulk containers for your (b)(4) Peeled Shrimp (Camaron Pelado) and Whole Shrimp (Camaron Entero) products indicate that salt is added; however this ingredient is not declared on your finished product label.
• In addition, Sample 631392, an official sample of (b)(4) Ground Shrimp (Camaron Molido) collected in 1 oz. retail packages at your firm was analyzed for the presence of sulfites and the results of the analysis by FDA's Denver Laboratory found that the sample contained a range between 352 to 375 ppm of sulfites. Furthermore, your finished product labeling does not declare the actual sulfiting agent (e.g. sodium metabisulfite or sulfur dioxide) in the product's ingredient statement to be in compliance with 21 CPR 101.4(a)(1). Certain consumers that have severe sensitivity or allergies to sulfite run the risk of allergic reactions if they consume this product.
4. Your retail (b)(4) Ground Shrimp (Camaron Molido), Peeled Shrimp (Camaron Pelado) and Whole Shrimp (Camaron Entero) 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 CPR 101.9G)(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.
5. Your (b)(4) Ground Shrimp (Camaron Molido), Peeled Shrimp (Camaron Pelado) and Whole Shrimp (Camaron Entero) 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)(2), 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.
We note that your Camaron Pelado and Camaron Entero product labels incorrectly declare "ING: Contains Sulfites." It is not clear whether or not this statement is an incomplete ingredient statement or an incorrect usage of the "Contains" statement under section 403(w)(1)(A).
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.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Robert McNab, Compliance Officer at 949-608-4409.
Alonza E. Cruse
Los Angeles District Office
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413