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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Southwind Foods Company 10-May-07

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

Public Health Service
Food and Drug Administration

 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


Warning Letter

May 10, 2007

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Sebastiano Galletti
President
Southwind Foods Company
2900 Ayers Ave.
Vernon, CA 90023

Ref. #: DEN-07-05S1

Dear Mr. Galletti:

An investigator from the U.S. Food and Drug Administration conducted an inspection of your seafood processing facility located at 760 West 1760 South, Salt Lake City, Utah, on February 26 - March 5, 2007. Our investigator found that you have serious violations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123) and the Current Good Manufacturing Practice regulation for foods, 21 CFR 110. In accordance with 21 CFR 123.6(g), failure of a processor 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 fishery products adulterated within the me aning of Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), [21 U.S.C. §342(a)(4)].

Accordingly, your firm's seafood products, such as, fresh and frozen fish, sushi, pasteurized crabmeat, shellfish, shrimp, lobster and smoked salmon, 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 FDA Fish and Fisheries Products Hazards and Controls Guidance through links on FDA's homepage at http://www.fda.gov.

The signific ant violations observed were as follows:

1. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures of checking and recording product temperatures at the receiving Critical Control Point (CCP) to control Listeria monocytogenes listed in your HACCP plan for Ready-To-Eat (RTE) sushi products and Clostridium botulinum listed in your HACCP plan for vacuum packaged smoked salmon and crab meat.

This is a repeat observation that you were previously notified of during inspections of your firm on December 11 - 15, 2003, March 14 - 15, 2002 and June 21 - 22, 2001.

In addition, your firm did not follow the calibration procedure of reviewing the cooler gauge calibration record at the refrigerated CCP to control histamine formation listed in your HACCP plan for histamine producing species of finfish.

This is a repeat observation that you were previously notified of during inspections of your firm on January 17 - 23, 2006 and November 16 - 19, 2004.

2. 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFC 123.6(a)and 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for fresh/frozen fish does not list the food safety hazard of metal fragments that may occur from the use of a band saw.

This is a repeat observation that you were previously notified of during inspections of your firm on December 11 - 15, 2003, March 14- 15, 2002 and June 21 -22, 2001.

3. You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor, during your daily sanitation monitoring, the health conditions of employees and the possible cross-contamination of your RTE products from insanitary objects.

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

Please 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 verifications 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 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.

For your information, your HACCP Plan states that for "Cooked, ready-to-eat products, smoked vacuum packed RTE" products stored in the "Cooler" the temperature will be visually monitored "Daily". The thermometer reading is actually recorded three times a day. However, FDA's Fishand Fisheries Products Hazards and Controls Guidance recommends that a continuous temperature monitoring procedure, such as a digital time/temperature data logger, a recorder thermometer or a high temperature 24-hour monitoring alarm be used to monitor raw material, in-process, or finished product refrigerated storage. If you do not chose to utilize one of these continuous monitoring devices, you should, in any event correct your HACCP plan to indicate that the "Cooler" temperature is checked and recorded three times a day as per your current policy.

Please send your reply to the Food and Drug Administration, P.O. Box 25087, Denver, CO 80225, Attention: William H. Sherer, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Mr. Sherer at (303) 236-3051.

Sincerely,

/S/

B. Belinda Collins
Denver District Director

cc: Mr. Terry A. Veenendaal
General Manager
Southwind Foods, Inc.
760 W. 1760 S.
Salt Lake City, UT 84104