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U.S. Department of Health and Human Services

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Enforcement Actions

Harry O. Hahn Seafood 10-Oct-06

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

Public Health Service
Food and Drug Administration

 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390



WARNING LETTER
07-PHI-01

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

October 10, 2006

Mr. Walter Hurleman, Owner
Harry O. Hahn Seafood
t/a Adelphia Seafood
3024 Penn Avenue
West Lawn, PA 19609-1421

Dear Mr. Hurleman:

We inspected your seafood processing facility, located at 3024 Penn Avenue, West Lawn, PA on May 15, 17 - 18, 2006. 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 seafood products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Additionally, or investigator collected samples of product labels for your ready-to-eat Seafood Dip, Jalapeno Krab Dip, and ready-to-heat Lobster Bisque. Our review of these labels reveal that the products are misbranded pursuant to Section 403 of the Act (21 U.S.C. § 403), and the food labeling regulations at 21 CFR Part 101. You may find the Act, FDA's regulations and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

HACCP Violations

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 have, and implement a written HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). 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's HACCP plans for "Soup Products" and "Processed Salads & Dips" do not list the food safety hazard of Clostridium. botulinum growth and toxin formation. Your practice of thawing unopened vacuum packaged seafood ingredients, and/or storing vacuum packaged finished products under chilled storage and cooler storage (i.e., with label statements such as "Keep Refrigerated") create a condition whereby Clostridium botulinum is a reasonable likely food safety hazard. Proper refrigeration temperatures are critical for thawing and storing your vacuum-packaged products. For more information on the hazard of Clostridium botulinum, please refer to Chapter 13 of FDA's Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.

> You must have and implement a written HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.", However, your firm's HACCP plans for the following products list critical limits that are not adequate to control the specified food safety hazard:

1. Your firm's HACCP plan for "Fresh Made Items (Breaded arid Unbreaded)" lists a critical limit, "disgard milk solution before [redacted] at your Kitchen/Breading Process critical control point that is not adequate to prevent Staphylococcus aureus growth and toxin formation. Specifically, your critical limit should ensure that the temperature of the batter does not exceed 70° F for more than three hours.

2. Your firm's HACCP plan for "Fresh Made Items (Breaded and Unbreaded)" lists a critical limit, "temperature not to exceed [redacted] at your "Chilled Storage/Thaw" critical control point that is not adequate to control pathogens. FDA recommends temperatures of 40° F or below for seafood products that are held for extended time periods under refrigerated conditions, such as during thawing and finished product storage.

>You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of observing the start and stop time of the breading process at the "Kitchen/Breading. Process" critical control point to control Staphylococcus aureus growth and toxin formation listed in your HACCP plan for "Fresh Made Items (Breaded and Unbreaded)."

> You must have and implement a written HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plans for the following products list monitoring frequencies that are not adequate to control the specified food safety hazard:

1. Your HACCP plan for "Soup Products" lists a monitoring frequency at the Cooling critical control point that is not adequate to control pathogen survival after cooking . Specifically, you should monitor the cooling rate of each lot of product, rather than [redacted]

2. Your HACCP plans for "Soup Products," "Processed Salads & Dips," and "Fresh Made Items (Breaded and Unbreaded)" list a monitoring frequency at the Cooler Storage critical control point that is not adequate to control pathogen growth. For products stored under refrigeration, FDA suggest the use of a method of continuous temperature monitoring such as, a high . temperature alarm with 24 hour monitoring capabilities that monitors the temperature of the cooler. This monitoring frequency should be continuous by the instrument itself with a visual check of the instrument at least once per day.

>Since you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for the following products are not appropriate:

1. Your corrective action plans for "Processed Salads & Dips" at the cooler storage critical control point to control pathogen growth proposes microbial testing as a method of determining if the food is safe. Sampling and testing does not provide adequate safety assurances for the entire lot. Additionally, your corrective action for "Processed Salads & Dips" at the "thaw" critical control point does not address the, disposition of exposed product.

2. Your corrective action plans for "Fresh Made Items (Breaded and Unbreaded)" at the chilled storage/thaw, cooler, storage, and Kitchen/Breading process critical control points to control pathogen growth and Staphylococcus toxin formation do ~not provide assurances . that unsafe product will not enter commerce or address the cause of the deviation. For instance, you propose to place product in the freezer as a corrective measure for high temperature exposure. However, cooling potentially unsafe product will not cause it to become safe. In addition, you propose microbiological testing as an option at the "cooler, storage/thaw" critical control point.

Labeling Violations

Your ready-to-eat Seafood Dip, Jalapeno Krab Dip and Imitation Krab Salad (16 Oz) products 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 fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. For example, according to the product labels, your Seafood Dip and Jalapeflo Krab Dip contain surimi, cream cheese, barbeque sauce, mayonnaise and sour cream; each of these ingredients contains two or more component ingredients. Similarly, the packaging provided by your firm's management for the Alaska Pollock ingredient in your Imitation Krab Salad product indicates that the ingredient contains two or more component ingredients. As specified in 21 CFR 101.4(b)(2), the requirement to list these component ingredients may be met by either parenthetically listing the component ingredients after. the common or usual name of the multi-component 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.

Your Lobster Bisque product is misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that it is composed of two or more ingredients, but the product label does not bear the common or usual name of each ingredient. During the investigation, your firm's management indicated that crawfish is an ingredient in your Lobster Bisque product; therefore, crawfish must be listed in the product's ingredient statement as specified under 21 CFR 101.4.

Your Imitation Krab Salad and Lobster Bisque products are also misbranded under section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels for these products fails to declare major food allergens present in the products in the manner specified in section 403(w): 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. The packaging for the Alaska Pollock ingredient used in your Imitation Krab Salad product indicates the ingredient has milk as a component ingredient. Crawfish, a Crustacean shellfish, is an ingredient in your Lobster Bisque product. Under section 403(w) of the Act, 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, 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 from which the major food allergen is derived 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)]).

The specific labeling requirements of section 403(w) can be accessed on our website at www.cfsan.fda.gov/~dms/alrgact.html. Further guidance and information on food allergens can be accessed on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.

In addition, your Imitation Krab Salad (16 oz and 251b Tubs), New England Clam Chowder (81b Tub), Jalapeno Krab Dip (41b), and Seafood Dip (4 lb) containers are all misbranded under section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] because the product labels fail to specify the place of business of the, manufacturer, packer, or distributor [see 21 CFR 101.5].

This letter may not list all the deviations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations and the Good Manufacturing Practice regulations (21 CFR Part 110). You are also responsible for ensuring that all of your products are labeled in compliance with the laws arid regulations enforced by FDA. Further, you have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violation products and/or injunction against the manufacturers and distributors of violative products.

We also note that during the May 2006 inspection, you stated that your firm's food products qualify for an exemption from nutrition labeling because the firm employs fewer than an average of 100 full-time equivalent employees and sells fewer than 100,000 units in the United States. As set out in 21 CFR 101.90)(18), a notice of exemption must be filed with FDA before the beginning of the time period for which exemption is claimed. As of October 4; 2006, FDA has not received your notice of exemption.

Please advise this office in writing, within 15 working days of receipt of this letter, as to the specific steps you have taken or will be taking to correct these violations, including the steps taken to assure that similar violations do not recur. Include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations. Copies of the revised labels should also be submitted.

We note that you corrected the template of the label for your Imitation Krab Salad product to include "milk" (an allergen) while the investigator was present. A part of your response, please indicate how you will correct the labels for the existing stock of this product.

Your response should be sent to Robin M. Rivers, Acting Compliance Officer at the address noted above.

Sincerely,

/S/


Thomas D. Gardine
District Director
Philadelphia District Office