Country Maid, Inc. 5/13/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN  55401 Telephone: (612) 334-4100 FAX: (612) 334-4142

May 13, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED 

Refer to MIN 11 – 28

William M. Carr
Chief Executive Officer
Country Maid, Inc.
1919 S. Kinnickinnic Avenue
Milwaukee, Wisconsin  53204-4030

Dear Mr. Carr:

We inspected your food processing facility located at 1919 S. Kinnickinnic Avenue, Milwaukee, Wisconsin, on December 8, 13, 15 and 16, 2010. Additionally, during the inspection, our investigators collected samples of some of your product labels, and returned to collect additional labels on May 4, 2011. 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 and 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 Shrimp Pasta Salad, Seafood Supreme, and (b)(4) Crab and Shrimp Salad with Tomato Basil Dressing 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, the Fish and Fisheries Products Hazards & Controls Guidance, and other FDA regulations through links on FDA’s home page at www.fda.gov.

Your significant violations were as follows:

• You must have a 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 plan for Fully Cooked Ready-to-Eat Fish and Shellfish Salads, Spreads, and Dips lists a monitoring frequency at the finished product cooler temperature critical control point that is not adequate to control pathogens.  Your HACCP plan lists a frequency of “ (b)(4) .”  In practice, you take (b)(4) documented temperatures per day during production and utilize the services of a third-party alarm company to conduct temperature monitoring. FDA recommends that in order to adequately ensure that products remain at or below 40°F, firms use equipment on-site (i.e., at the facility capable of continuously monitoring and recording cooler storage temperatures on a 24-hour a day, 7 days per week basis with a daily check of temperature monitoring record and a daily check of the equipment). 

• You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor for the prevention of cross-contamination from insanitary objects to food and food contact surfaces with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by the use of high pressure hoses during cleaning of equipment and flooring which resulted in the splattering of dirty water onto raw ingredients and clean food contact surfaces, and the storage of food strainers on the floor on top of floor drains during production and then using the strainers for transfer of cooked in-process product.

• 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). However, your firm’s HACCP plan for Fully Cooked Ready-to-Eat Fish and Shellfish Salads, Spreads, and Dips does not list the food safety hazard of allergens and sulfite sensitivity. Your finished salad products may contain allergenic substances and food intolerance substances (sulfites) specifically associated with your shrimp products. 

We may take further action if you do not promptly correct these violations.  For instance, we may seize your products and/or enjoin your firm from operating.

We also have the following comments regarding your product labels:

• The labels for your Seafood Supreme salad (5 lbs) and Crab & Shrimp salad with Tomato Basil Dressing (5 lbs) products do not properly declare the net quantity of contents, as required by 21 CFR 101.105.  Specifically, under 21 CFR 101.105(f), the declaration shall, among other requirements, appear as a distinct item on the principal display panel, shall be separated from other printed label information appearing above or below the declaration, and shall be placed on the principal display panel within the bottom 30 percent of the area of the label panel.

• The label for your Seafood Supreme salad (12 oz) does not declare the number of “servings per container” in accordance with 21 CFR 101.9(b)(8).  For random weight products, you may declare “varied” for the number of servings per container provided the nutrition information is based on the reference amount expressed in ounces, 21 CFR 101.9(b)(8)(iii).  The reference amount for “All other salad” types is expressed in grams, not ounces; therefore your product is not eligible to use the term “varied” to identify the number of servings per container.

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, revised labels, 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 firm is in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). 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: Tyra S. Wisecup, Compliance Officer, at the above address.  If you have questions regarding any issues in this letter, please contact Ms. Wisecup at (612) 758-7114.

Sincerely,

/s/

Gerald J. Berg
Director
Minneapolis District

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