Inspections, Compliance, Enforcement, and Criminal Investigations
Acquired Holding Inc
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
February 24, 2010
VIA FEDERAL EXPRESS
WARNING LETTER CIN-10-89104-06
Michael T. McAllister, Owner
Acquired Holding, Inc.
4505 Mattingly Court
Buckner, KY 40010-8830
Dear Mr. McAllister:
We inspected your seafood processing facility, located at 4505 Mattingly Court, Buckner, KY between 10/23/2009 and 11/20/2009. 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 thawed vacuum-packed tilapia, pasteurized canned crabmeat, and Lemon Pepper catfish products 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.
Review of the labels for your tilapia, salmon and catfish products also revealed that these products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343].
Your significant violations are 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:
o Tilapia that you receive frozen and sealed in modified air packaging, to control the food safety hazard of Clostridium botulinum growth and toxin formation during the extended thawing period that you conduct under refrigerated conditions while the packages remain sealed. Alternatively, because the Clostridium botulinum toxin hazard is not reasonably likely in the absence of the vacuum seal, your firm may wish to break the vacuum seal on each package prior to thawing to eliminate the hazard.
o Lemon Pepper Catfish, to control the food safety hazard of undeclared allergenic substances associated with the ingredient FD&C Yellow #5 in this product. FDA recommends that your plan include a label review of every lot of labels to ensure that the ingredient statement includes the presence of FD&C Yellow #5 or other undeclared allergenic substances. For additional information regarding controls for allergenic substances/ingredients, please refer to Chapter 19 of the Fish and Fisheries Products Hazards and Control Guidance: 3rd Edition.
• You must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each critical control point, 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 plan for "CRABMEAT (FRESH)," which you use as your plan for your pasteurized canned crab meat product, lists a critical temperature limit at the "receiving" and "storage in cooler" critical control points that is not adequate to control for the hazard of "biological temperature," meaning the control of pathogen growth and potential toxin formation, including, for example, the formation of Clostridium botulinum toxin. Your plan lists a critical temperature limit of "45°F Maximum." However, FDA recommends that products such as pasteurized crabmeat be maintained consistently at or below 40°F to appropriately control for the hazard of pathogen growth and toxin formation.
• You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "CRABMEAT (FRESH)," which you use as your plan for your pasteurized canned crab meat product, lists monitoring procedures that are not adequate to control for the hazard of "biological temperature," meaning the control of pathogen growth and potential toxin formation, including, for example, the formation of Clostridium botulinum toxin. Specifically:
o Your plan provides that you will take the temperature of"every shipment" at the "receiving" critical control point. However, this action provides no information related to the temperatures of the products during transit to your facility. FDA recommends that firms maintain a record of the transit temperatures for the entire duration of the transit time to the facility to ensure that proper temperatures are continuously maintained during transit.
o Your plan provides that you will take cooler temperatures "once a day at start-up" at the "storage in cooler" critical control point. However, this action provides no information related to the temperatures of the cooler between the daily start-up checks. In addition, this monitoring frequency does not adequately monitor the cooler temperatures when your film in not in operation. FDA recommends that films use equipment capable of providing a record of the cooler temperatures on a 24 hour a day/7 day a week basis, with a daily check of the record and of the equipment. This is particularly important because your firm is also conducting thawing of fresh vacuum packaged fish in your cooler.
Your tilapia, salmon and catfish products are misbranded within the meaning of Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading because the label states in part, "This product was prepared from inspected and passed meat and/or poultry." The products under review are seafood and not meat and/or poultry; therefore, the label declaration does not apply to these products and is false.
• Your Lemon Pepper Catfish and Spicy Cajun Catfish products are misbranded under Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but their labels fail to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4. For example:
o Your Lemon Pepper Catfish and Spicy Cajun Catfish products fail to list the following sub-ingredients of their marinades in accordance with 21 CFR 101.4(a):
• Lemon Pepper Marinade: Sodium tripolyphosphate, sodium chloride, onion, garlic, corn syrup solids, citric acid, xanthan gum, lemon solids, natural lemon flavor, and FD&C yellow no. 5
• Spicy Cajun Marinade: Sodium tripolyphosphate, paprika, spices, sodium chloride, onion, garlic, xanthan gum, citric acid, natural flavor, and less than 2% tricalcium phosphate used to prevent caking
• The outer container of your wholesale Catfish box lists multiple ingredients that are not included in the ingredient statement of your Lemon Pepper Catfish and Spicy Cajun Catfish products. For instance, water and sodium hexametaphosphate are not listed as ingredients for the Lemon Pepper Marinade and sodium hexametaphosphate is not listed as an ingredient for the Spicy Cajun Marinade.
The requirement to list these component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient or by listing the component ingredients without listing the main 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 Lemon Pepper Catfish product package label bears the name of a manufacturer that did not supply the catfish used in the product. The manufacturer listed on the label is Southern Pride Catfish, P.O. Box 436, Greensboro, AL 36744; however, (b)(4) supplied the catfish used in the product. This product is therefore misbranded within the meaning of Sections 403(a)(1) and 403(e)(1) [21 U.S.C. § 343(e)(1)] of the Act in that the package label is false and does not contain the name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5.
We also note that the label for the Cajun Catfish includes the statement "Allergen Information: Contains Fish." This statement is not required on this product because "Catfish" is declared in the ingredient statement. However, if you voluntarily include an allergy "Contains" statement, the species offish must be declared and the statement must be in the format required by section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)].
We may take further action if you do not promptly correct these violations. For instance, we may take 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.
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 and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Stephen J. Rabe, at the address listed in the letterhead. If you have questions regarding any issues in this letter, please contact Mr. Rabe at 513-679-2700, ext. 163.
Teresa C. Thompson