Inspections, Compliance, Enforcement, and Criminal Investigations
Cucina Fresca, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
February 25, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-16
Bradley L. Glaberson, President
Cucina Fresca, Inc.
8300 Military Road South, Suite 120
Seattle, Washington 98108
Dear Mr. Glaberson:
We inspected your food processing facility, located at 8300 Military Road South, Seattle,
Washington, on October 27, 28, 29, and November 2, 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, 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, including
the sanitation control procedures under 21 CFR 123.11, 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 ravioli
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.
Your significant violations were as follows:
1. You must have a HACCP plan that lists the critical control points, to comply with 21 CFR 123.6(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." However, your firm's HACCP plan does not list the critical control point (CCP) of refrigerated storage for controlling the food safety hazard of pathogen growth and toxin production in the crab, lobster, and smoked salmon filling used your ravioli products. Specifically, you do not list the processing step where the prepared crab, lobster, and smoke salmon filling is held in your walk-in refrigerator (b)(4) prior to being used to fill the finished product as a CCP in your HACCP plans for your seafood ravioli products.
2. Because you chose to include corrective action plans in your HACCP plans for your crab, lobster, and smoked salmon ravioli products, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans to control the hazards of pathogen growth and toxin production and allergens are not appropriate as follows:
a. Your listed corrective action plans for your crab and lobster ravioli products at the thawing and labeling CCPs do not describe the steps to be taken to ensure that the cause of the deviation is corrected.
b. Your listed corrective action plan for your smoked salmon ravioli at the thawing CCP does not describe the steps to be taken to ensure that the cause of the deviation is corrected.
c. Your listed corrective action plan for your lobster ravioli at the cooking CCP does not describe the steps to be taken to ensure that affected product is not entered into commerce or to ensure that the cause of the deviation is corrected.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the "Labeling" critical control point to control the hazard of allergens listed in your HACCP plans for your lobster ravioli products. Specifically, your HACCP plan lists your monitoring record for this CCP as a "Label log," which your firm further identified during our inspection as a document titled "Cucina Fresca Packaging Station Daily Pack List"; however, monitoring observations pertaining to examination of finished product labels for the declaration of allergens are not being recorded on the document identified as your label log.
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.
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, 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 written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen