Race Street Foods, Inc

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510/337-6700

WARNING LETTER

VIA UPS

November 9, 2010
 

Michael R. Barsanti, Secretary/Treasurer
Race Street Foods, Inc.
1130 Olinder Ct.
San Jose, CA 95122

Dear Mr. Barsanti:

We inspected your seafood processing facility and warehouse located at 1130 Olinder Ct., San Jose, CA 95122 on September 7, 8, and 10, 2010. 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 (21 CFR 123). 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 tins 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 fresh, refrigerated seafood products, including unpasteurized Dungeness crabmeat in cans, 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 are as follows:

1) 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, at a minimum, are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). 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 does not have a HACCP plan for your reduced oxygen packaged seafood products, including, refrigerated, unpasteurized, canned Dungeness crabmeat, to control the food safety hazard of pathogen growth and toxin formation including. Clostridium botulinum growth and toxin formation.

Clostridium botulinum toxin formation is a reasonably likely hazard associated with products that are packaged in materials that create a reduced oxygen atmosphere. In addition, when refrigeration is the sole barrier to outgrowth of nonproteolytic Clostridium botulinum, for example for products that are cooked, but then handled and subsequently packaged in reduced oxygen materials with no further preservation or pasteurization process applied, the products need to be continuously maintained at or below 38° F. For more information related to the hazard of pathogen growth, please refer to Chapter 12 of the Fish and Fisheries Hazards and Controls Guidance: 3rd Edition (the Hazard Guide), and for more information related to Clostridium botulinum, please refer to Chapter 13 of the Hazard Guide. 

2) Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, 
 

a) Your corrective action plans for "Fish fillets" at the "Receiving" Critical Control Point to control pathogen formation are not appropriate. Specifically, your corrective action plans do not resolve how the cause of the deviation will be corrected.
b) Your corrective action plans for "Scombroid Species" at the "Receiving" Critical Control Point to control histamine formation are not appropriate. Specifically, your corrective action plans do not ensure that unsafe product does not reach the consumers and do not resolve how the cause of the deviation will be corrected.

The above violations are not intended to be an all-inclusive list of violations at your firm.

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 reply to the Food and Drug Administration, Attention: Juliane K. Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issues in this letter, please contact Ms. Jung-Lau at (510) 337-6793.

Sincerely,
/S/
Barbara J. Cassens
District Director
San Francisco District
 

cc: Paride Riparbelli, President
Race Street Foods, Inc.
1130 Olinder Ct.
San Jose, CA 95122
 

David Riparbelli, Vice President
Race Street Foods, Inc.
1130 Olinder Ct.
San Jose, CA 95122
 

Daniel M. Barsanti, Vice President
Race Street Foods, Inc.
1130 Olinder Ct.
San Jose, CA 95122
 

James P. Riparbelli, Vice President
Race Street Foods, Inc.
1130 Olinder Ct.
San Jose, CA 95122
 

Gino Barsanti, Chairman of the Board
Race Street Foods, Inc.
1130 Olinder Ct.
San Jose, CA 95122
 

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