Inspections, Compliance, Enforcement, and Criminal Investigations
Morey's Seafood International, LLC 08-Jul-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
July 8, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08 - 14
Lynn M. Girouard
Morey's Seafood International, LLC
1902 South Lane
Mendota Heights, Minnesota 55118
Dear Ms. Girouard:
We inspected your seafood processing facility located at 1218 Highway 10 South, Motley, Minnesota, on January 28-February 7, 2008. We found that you have serious violations of 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 and 110) and the 21 CFR Part 101, Food Labeling regulations.
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 Hot Smoked Fish and Frozen Fish, Fillets Marinated are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or 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.
Your significant violations are as follows:
1. You must monitor sanitation conditions and practices during processing, with sufficient frequency to ensure, at a minimum, 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:
a. Your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, as evidenced by the following:
• There were no backflow prevention devices on the hose bibs in the smoke room, raw processing area, thawing room, small and large brine room, take-down area, and finished product-packaging area.
b. Your firm did not monitor the condition and cleanliness of food contact surfaces, as evidenced by the following:
• Totes used to hold finished product were observed in storage. The totes observed contained residual water and old build-up of product.
c. Your firm did not monitor for the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, as evidenced by the following:
• Several employees were observed touching insanitary objects, such as cooler handles, and pallet jacks spray bottles, and then handling ready-to-eat items without first washing his/her hands.
• A marinade kettle was observed covered by apiece of cardboard. The cardboard was set on the floor as the marinade was mixed, and then place back as a cover.
• While tables used in processing were being cleaned on the floor with a high pressure hose, spray from the hose was observed splashing into a kettle of uncovered marinade.
2. 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 a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6 (a) and (c) (2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."
a. However, your firm's HACCP plan for Hot Smoked Fish and Frozen Fish Fillets Marinated does not list a critical control point for controlling the food safety hazard of sulfites. Specifically, one of your ingredient's includes sulfites, You have no critical control point to either ensure that your finished product is labeled as containing sulfites or to demonstrate that your finished product does not contain detectible sulfites.
b. However, your firm's HACCP plan for Hot Smoked Fish does not list the critical control point of "Cooling" for controlling the food safety hazard of pathogen growth following the cook step. The holding area is not refrigerated, and time and temperature are not monitored before the products are moved into the blast freezer.
The labeling violations we note are as follows:
1. Your Morey's Marinated Salmon Lemon Dill product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the presence of the major food allergens wheat and milk, as required by section 403(w)(1) of the Act. The ingredient statement in the label for your Marinated Salmon Lemon Dill product states that the product contains "marinade." Your "marinade" is made with "Lemon Pepper Seasoning" containing milk and wheat, however the "marinade" sub-ingredients listed on the label for your Marinated Salmon Lemon Dill product does not list milk or wheat.
Section 201(qq) of the Act [21 U.S.C. 321 (qq)] defines 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, as "major food allergens." 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:
• 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 (e.g., "whey,(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)].
2. Your Lemon Dill Marinated Salmon, product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product label fails to bear the common or usual name of each ingredient. Your products are fabricated using ingredients composed from two or more sub-ingredients but all of the ingredients are not declared on the label. For example:
The label for your Lemon Pepper Seasoning declares non fat dry milk, dehydrated onion, and celery but the label for the Lemon Dill Marinated Salmon, which contains the Lemon Pepper seasoning, fails to include these ingredients in the ingredient statement as required under 21 CFR 101.4(b)(2).
You should respond in writing within 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.
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 acknowledge receipt of your written responses by letter dated March 19, 2008, and e-mail dated March 23, 2008. You did not address all of the issues, and those that were addressed were incomplete. In response to sanitation you state that the plant has had initial training on February 9 and February 16, 2008, on general GMPs and daily personnel practices but do not explain how overlapping shifts will accommodate. the new QC Technicians assigned one per shift to do pre-ops before each shift starts.
This letter may not list all the violations at your facility. You are, responsible for ensuring, that your seafood establishment operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and the Food Labeling Regulations, (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.
Your Lemon Dill Marinated Salmon label bears the claim "Salmon is rich in 0mega 3's." The nutrient content claim "Rich in Omega 3's". has not been authorized by regulation or by the Federal Food, Drug and Cosmetic Act.
The declaration of percent Daily Value (DV) for vitamins listed in the nutrition label must be expressed to the nearest 2-percent increment up to and including the 10 percent level (see 21 CFR 101.9(c)(8)(iii)). However, your Lemon Dill Marinated Salmon label states a 7-percent DV of Vitamin A. Additionally, total carbohydrate that is listed in the DV column must be expressed to the nearest Whole percent [see 21 CFR 101.9(d)(7)(ii)]. However, your Lemon Dill Marinated Salmon Label states that the product contains 0.5 percent total carbohydrate.
The label for your Wild Alaskan Cajun Smoked Salmon, which is applied with your "Blackened Seasoning", containing "less than 2% partially hydrogenated soybean oil as a processing aid," fails to declare the presence of the major food allergen soybeans. If this is not highly refined oil as explained in section 201(qq) of the Act [21 U.S.C. § 301 (qq).(2)], then your Wild Alaskan Cajun. Salmon would be misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)].
The ingredient statement in the label for your Marinated Salmon lemon Dill product lists "natural butter flavor enzyme modified butterfat." If this ingredient contains milk protein, this product would be misbranded within the meaning of section 403(W) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the presence of the major food allergen milk.
Any further replies should be directed to Compliance Officer Jane Nelson at the address indicated on the letterhead.
W. Charles Becoat
xc: Patti L. Zahler
Morey's Seafood International, LLC
P.O. Box 248
Motley, MN 56466-0248