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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Carso's Pasta Company 7/18/06


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

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

July 18, 2006


In reply refer to Warning Letter SEA 06-38
David A. Brown, President
Carso's Pasta Company
5530 208th Street SW
Lynnwood, Washington 98036-71633


Dear Mr. Brown:

We inspected your seafood processing facility, located at 5530 208th Street SW, Lynnwood, Washington, on March 29-30, and April 3, 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 Smoked Salmon Filled Pasta is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the regulations and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Significant HACCP Violations:

You must conduct a hazard analysis 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: Part 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." However, your firm's HACCP plan for Smoked Salmon Filled Pasta does not list the critical control point of finished product storage for controlling the food safety hazard of pathogens.

Also, you are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices to comply with 21 CFR 123.11(b)(1) through (8). Your SSOP form covering the eight points of sanitation is only filled out one time per week regardless how many times the firm has processed seafood products. The form should be completed each time processing has been conducted. Our investigator observed the following, which were not listed on the sanitation monitoring records:

a. An employee was observed filling a bag of soup and then proceeded to place her finger in the bag of soup, take it out and put her finger her mouth and then put her finger back in the soup bag.

b. Two plastic light covers directly over the tortellini processing area and the pasta area were cracked and missing plastic sections.

c. Duct tape, with grime and residue on it, was used to hold the back cover of the tortellini machine.

d. A dish towel/rag is used to hold the tortellini roll of dough in place. This rag is changed on a daily basis; however, this contact surface is difficult to keep clean over the 4-8 hour processing time.

e. Employees on the lasagna line were observed wearing stud earrings. 


Your sanitation control records do not accurately document the conditions or practices observed at your firm. According to 21 CFR 123.11 (c), each processor shall maintain sanitation control records that at a minimum, document the monitoring and corrections prescribed by the eights points in the previous paragraph.

You should take prompt action to correct the conditions that led to the above-described violations. Failure to promptly correct the recurrent labeling violations at your firm may result in regulatory action without further notice. The Act provides for the seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products.

In addition, we acknowledge that you conducted a recall of your Merlino's Brand Hazelnut Tortellini (10 lb. package) because the ingredient list failed to list pasteurized eggs. We advise that section 403(i) of the Act requires a food fabricated from two or more ingredients to list those ingredients by common or usual name on the food's label.

We note that in the past you have conducted three previous recalls for labeling-related issues, beginning in 2001. In 2001, you recalled your Smoked Salmon Tortellini for failure to declare Yellow #6 on the product label. In 2004, you conducted a recall of your Tuna Noodle Casserole for failure to declare eggs on the product label.

You should respond in writing within fifteen (15) working days from your receipt of this letter. You should also 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 note that you amended your labels for your Merlino Brand Hazelnut Tortellini during the inspection and provided the investigator with revised labels. Your response to this letter should describe the actions taken to ensure that your product labels will accurately reflect the ingredients in the products in the future.

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, 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.

Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington. If you have questions regarding any issues in this letter, please contact CO Elrand at 425-483-4913.



Charles M. Breen
District Director