Inspections, Compliance, Enforcement, and Criminal Investigations
BJ Packers Inc. 16-Oct-08
Department of Health and Human Services
Public Health Service
San Juan District Office
October 16, 2008
RETURN RECEIPT REOUESTED
Mrs . Barbara Altman
BJ Packers Inc.
PO Box 9524
San Juan, PR 00908-9524
Dear Mrs. Altman:
We inspected your seafood processing facility, located at Carr# 3 Km 82.5 Zona Industrial Catano Humacao, PR 00791 on May 28, 2008 through June 9, 2008. 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 Part 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 product cooked ready-to-eat crabmeat stew product is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
In addition, after careful review of your product labels, we found your products (b)(4) (b)(4) and (b)(4) and (b)(4) and (b)(4) to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance: 3rd Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
• 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 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). However, your firm does not have a HACCP plan for your (b)(4) product to control the food safety hazards of pathogen growth and toxin formation.
Your hazard analysis should evaluate the hazards of pathogen growth and toxin formation. Once you have conducted a hazard analysis for your (b)(4) product, your HACCP plan must, at a minimum, list hazards that are reasonably likely to occur and include appropriate critical control points, critical limits, monitoring procedures, any corrective action plans you have developed to address deviations from critical limits, verification procedures, and recordkeeping activities to ensure that the food safety hazards are controlled.
We acknowledge that during the inspection, you submitted a document entitled "Hazard Analysis Form." However, this document does not include the necessary components of a HACCP plan.
• 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 record "Inspection Pre-operacional" used to document your sanitation controls does not document the monitoring of the following sanitation elements: (1) safety of water that comes into contact with food or food contact surfaces, (2) protection of food, food packaging material, and food contact surfaces from adulteration; (3) proper labeling, storage, and use of toxic compounds, (4) control of employee health conditions, and (5) exclusion of pests.
• Your (b)(4) is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] because the label fails to list the food allergen milk. 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:
1. 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
2. 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., "casein (milk)"), 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)].
Additionally, the labels for the (b)(4) (b)(4) include the allergen "Contains" statement in the Nutrition Facts panel, not immediately after or adjacent to the list of ingredients, as required by section 403(w)(1)(A) of the Act.
• Your (b)(4) and (b)(4)are misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labels are false or misleading. The product names and labels state or suggest that the products are made with real cheese, but the ingredient statements indicate that the products are made with imitation cheese. Specifically:
1. The ingredient statement of your (b)(4) product declares "imitation mozzarella cheese blend," but the front panel bears the statement "stuffed with rich pizza sauce and mozzarella [sic] cheese"
2. The ingredient statement of your (b)(4) product declares "Pasteurized process cheese substitute," but the front panel bears the statement "filled with cheese, lots of cheese!"
3. The ingredient statement of your (b)(4) product declares "Imitation Cheddar Cheese," but the front panel bears the statement "lots of cheese!"
• Your (b)(4) and (b)(4) are misbranded under section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] because the labels do not declare the name and place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5. The labels declare that the products were manufactured and packed in a processing plant named (b)(4). However, these products were manufactured and packed at B.J. Packers, in Humacao, PR, for (b)(4) a firm located in (b)(4)
• Your (b)(4) and (b)(4) are misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they are fabricated from two or more ingredients and the ingredients are not declared on the label. Specifically, the ingredient statements for these products read, in part: "Wheat Flour (all purpose enriched)." The enriched wheat flour is comprised of several sub-ingredients that are not included on these labels [21 CFR 101.4(b)(2)].
• The ingredient statement for your (b)(4) lists "kasal sodium phosphates." Under 21 CFR 101.4(a), this ingredient must be declared by its common or usual name, "sodium aluminum phosphate."
• Your (b)(4) and (b)(4) are misbranded under section 403(q) of the Act [21 U.S.C. 343(q)] because the product labels fail to declare the amount of trans fat, as required by 21 CFR 101.9(c)(2)(ii).
This letter may not list all the violations at your facility. 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. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should 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, 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.
For your information when revising your product labels, please note that labels that use both English and Spanish must include all required information in both languages. Products distributed solely in Puerto Rico may labeled solely in Spanish [21 CFR 101.15(c)(1)]; however, if they contain any information in another language, such as English, all of the required label information must appear in both languages [21 CFR 101.15(c)(2)].
Please send your reply to the Food and Drug Administration, Attention: Margarita Santiago, Compliance Officer, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico, 00901-3226. If you have questions regarding any issues in this letter, please contact Ms. Santiago at 787-474-4789.
San Juan District
Enclosure: FDA 483