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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Canada Food Outlet, Inc. 29-Sep-05

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

Public Health Service
Food and Drug Administration

 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone312-353-5863


 

September 29, 2005

WARNING LETTER
CHI-10-05

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Peter Baranchuk, Owner
Canada Food Outlet, Inc.
270 Larkin Drive, Unit B
Wheeling, IL G0090

Dear Mr. Baranchuk:

On June 23 and 27, 2005 the Food and Drug Administration (FDA) conducted an inspection of your firm, located at 270 Larkin Drive, Unit B, Wheeling, IL 60090. The inspection was conducted to determine your firm's compliance with FDA's seafood Hazard Analysis and Critical Control POint (HACCP) regulations, Title 21, Code of Federal Regulations (CFR), Part 123 "Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products" (21 CFR 123). 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 21 CFR Part 123, renders the fishery products adulterated within the meaning of Section of 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(4). You may find the Act and the seafood HACCP regulations through links in FDA's home page at http://www.fda.gov.

During our inspection, the FDA investigator observed deviations from the seafood HACCP regulations. The FDA investigator provide [redacted] Manager, with a Form FDA 483, which present her evaluation of your firm's performance regarding various aspects of the HACCP requirements. A copy of this form is enclosed for your convenience. The observations of of concerns to us are as follows:

Deviations by your firm from the special requirements for imported products {21 CFR 123.12):

  • You must have product specifications that are designed to ensure that the fish and fishery products you import are not adulterated under Section 402 of the Act, 21 U.S.C. 342 , because they may be injurious to health or have been processed under insanitary conditions to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for any fish products you import from [redacted] including refrigerated smoked salmon, smoked mackerel, smoked whitefish, smoked sturgeon, smoked halibut, smoked sprats, and dried whitefish.

  • You must have and implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm does not have and did not perform an affirmative step for any fish products you import from [redacted] including refrigerated smoked salmon, smoked mackerel, smoked whitefish, smoked sturgeon, smoked halibut, smoked sprats, and dried whitefish.

Deviations by your firm from the domestic seafood HACCP regulations:

  • You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process, and you must have a written HACCP plan (or plans) to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b) . However, your firm did not conduct a hazard analysis and does not have a HACCP plan (or plans) for any your refrigerated seafood products. A hazard analysis may determine that you need a HACCP plan, for example, to control the food safety hazard of scombrotoxin (histamine) formation in your salted herring in brine, smoked mackerel, and smoked sprats.

In addition, although the FDA investigator determined that your firm no longer handles vacuum-packaged seafood products, please note that packaging product in deep containers from which the air is expressed, such as your salted herring in brine that is packed in 30 lbs. containers, creates a reduced oxygen environment from which it is likely that the food safety hazard of Clostridium botulinum can occur.

Please note that above-listed deviations were brought to your firm's attention in our letter of December 1, 2004. The above-listed deviations are not intended to be an all- inclusive list of deficiencies at your facility. It is your responsibility to ensure that all seafood products processed and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.

You should take prompt action to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action may include seizure and/or injunction. In addition, FDA may detain your imported seafood product without examination. Under such conditions, the FDA will not issued Certificated for Export or European Union Health Certificates for any of the affected fish and fishery products processed at your facility.

Please notify this office in writing 15 working days from your receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their recurrence. your response should include copies of any available documentation demonstrating that corrections

Please send your response to the Food and Drug Administration, Attention: Patrick J. Brown, Compliance Officer, 550 W. Jackson Boulevard, 15th Floor, Chicago, Illinois, 60661-5716. If you have any questions regarding any issue in this letter, please contact Mr. Brown at (312) 596-4214. We look forward to working with you to achieve a successful HACCP program.

Sincerely,

/S/

Scott J. MacIntire
District Director

Enclosure: Form FDA 483, dated June 27, 2005

cc:

Mr. Sergey Bugaev, Owner
Canada Food Outlet, Inc.
270 Larkin Drive, Unit B
Wheeling, IL 60090

Mr. Aleksey Grinberg, Manager
Canada Food OutIet, Inc,
270 Larkin Drive, Unit B
Wheeling, IL 60090