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Department of Health and Human ServicesWARNING LETTER
11-PHI-10
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
April 6, 2011
James L. Norton, II, President
Chesapeake Crab Connection Co.
2834 Columbia Avenue
Lancaster, PA 17603-7024
Dear Mr. Norton:
We inspected your seafood processing facility, located at 2834 Columbia Avenue, Lancaster, PA on December 16-21, 2010. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 Vacuum Packaged Frozen Crab Cakes and Ready-To-Eat Steamed Crabs are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Furthermore, our inspection revealed that your Vacuum Packaged Frozen Crab Cakes are not labeled and are therefore misbranded under sections 403(e), 403(i), 403(q) and 403(w) of the Act [21 U.S.C. 343(e), 343(i), 343(q), and 343(w)] and FDA’s implementing regulations in Title 21, Code of Federal Regulations , Part 101.
In addition, your facility is not registered with FDA as required by section 415 of the Act [21 U.S.C. 350d] and FDA’s regulations in 21 CFR Part 1, Subpart H. You may find the Act, the labeling and Seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
Seafood HACCP
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 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 HACCP plans for your Vacuum Packaged Frozen Crab Cake and Ready-To-Eat Steamed Crab products to control the food safety hazards of pathogen growth and toxin formation.
2. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, sanitation deficiencies were observed in areas that should have been monitored by your firm, as specified below:
• Your firm did not monitor the safety of water that comes into contact with food or food contact surfaces as evidenced by the lack of backflow prevention devices on hoses equipped with pressure nozzles identified for sanitation use in the refrigerated storage area for live crabs and in the finished product packaging area.
• Your firm did not monitor the prevention of cross-contamination from insanitary objects to food as evidenced by employees observed preparing Vacuum Packaged Frozen Crab Cakes without hair restraints or beard covers.
3. 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 does not maintain any sanitation monitoring records for 1) the safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; 2) condition and cleanliness of food contact surfaces; 3) prevention of cross-contamination from insanitary objects to food; 4) maintenance of hand washing, hand sanitizing, and toilet facilities; 5) protection of food, food packaging material, and food contact surfaces from adulteration from chemical, physical, and biological contaminants; 6) proper labeling, storage, and use of toxic compounds; 7) control of employee health conditions; and 8) exclusion of pests.
Labeling
During the inspection our investigator was informed that none of the products distributed by your firm are labeled with the information required by the Act and FDA regulations. You provided our investigator with information regarding the labeling/shipping of your Vacuum Packaged Frozen Crab Cakes. You stated that the crab cakes are manufactured with the ingredients of jumbo lump crabmeat, mayonnaise, old bay seasoning, breadcrumbs, and pepper and then blast frozen. They are vacuum-packaged into clear plastic bags in units of one, four, six, or twelve. The plastic bags are unlabeled and serve as the product packaging. When an order is placed, the crab cakes are shipped to customers via UPS in a styrofoam shipping container with a frozen gel pack below and on top of the bag. The shipping container is placed in a cardboard box and a product insert that describes cooking instructions is included in the box and shipped to the customer.
Based on our inspection at your facility, the labeling violations we noted are as follows:
4. Your Vacuum Packaged Frozen Crab Cakes product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the product fails to declare the major food allergens present in the product as required by section 403(w)(1) of 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 certain exceptions, e.g., highly refined oils derived from a major food allergen. Further, a food is misbranded under section 403(w) of the Act 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, 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)].
During the inspection, our investigator observed that your Vacuum Packaged Frozen Crab Cakes are manufactured from ingredients that contain major food allergens, including crustacean shellfish, soy, egg, wheat, and milk. However, none of these major food allergens are declared on the labels of your finished products.
5. Your Vacuum Packaged Frozen Crab Cakes are misbranded under section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that the product fails to bear a label with a statement of identity in accordance with 21 CFR 101.3.
6. Your Vacuum Packaged Frozen Crab Cakes are also 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 their label fails to list the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1).
Your Vacuum Packaged Frozen Crab Cakes are also manufactured using multi-component ingredients that are themselves composed of two or more ingredients, including mayonnaise and bread crumbs. For multi-component ingredients the requirement to list the component ingredients (or “sub-ingredients”) may be met by either (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or (2) listing the component ingredients without listing the common ort usual name of the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
7. Your Vacuum Packaged Frozen Crab Cakes are misbranded under section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that they fail to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Your Vacuum Packaged Frozen Crab Cakes are also misbranded under section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that they fail to bear a net quantity of contents statement in accordance with 21 CFR 101.105.
8. Your Vacuum Packaged Frozen Crab Cakes are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the product fails to provide nutrition information in accordance with 21 CFR 101.9. We are not aware that your firm qualifies for any exemptions from this requirement.
Registration
In addition, the FDA has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act [21 U.S.C. 331(dd)]. Our records indicate that, to date, your facility has not been registered with FDA.
We request that the owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
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.
We are aware that you process seafood products other than the ones discussed above. Please note that for each kind of fish and fishery product that you produce you must conduct or have conducted for you a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and 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).
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.
This letter may not list all the violations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including 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.
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov
Sincerely,
/s/
Kirk D. Sooter
District Director
Philadelphia District
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