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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Food Concepts, Inc. 07-Apr-05

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: 303-238-3100



Warning Letter

April 7, 2005

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Susan K. Smith
President
Food Concepts, Inc.
2545 Kipling St.
Lakewood, CO 80215

Dear Ms. Smith:

During the period December 21, 2004 through January 5, 2005, an investigator from the Denver District office of. the Food and Drug Administration conducted an inspection of your seafood processing facility located at 2545 Kipling St., Lakewood, Colorado, and found that you have serious deviations from the seafood Hazard,Analysis and Critical Control Points (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 to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the req,uirements of this part, renders the 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)].

The deviations cause your Boston's Best Clam Chowder to be adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it 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 deviations observed were as follows

1. 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 123 .3(b) gs 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 HACCP plan does not list a critical control point for post pastetnizationlhot filling control for the food safety hazard of pathogen growth and toxin formation.

2. 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 implement the following monitoring procedures listed in your HACCP plan.

  • Your firm failed to utilize a continuous monitoring device at the "Cooling" critical control point to control the food safety hazard of pathogen growth and toxin formation listed in your HACCP plan. Your HACCP Critical Control Points Daily Temperature Log & Pre-Shipment log documents that the clam chowder temperature is determined and recorded only [redacted] in the cooling process. This temperature check occurs one hour after starting the cooling process.

  • Your firm failed to check the continuous monitoring device [redacted] times during cooking at the "Processing and Cooking" critical control point to control the food safety hazard of pathogen growth and toxin formation listed in your HACCP plan.

3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3) . A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your HACCP plan fails to adequately list critical limits at the following critical control points.

  • Your HACCP plan lists an inadequate critical limit of "greater than or equal to [redacted] for no specified time, at the "Processing and cooking" critical control point, to control the food safety hazard of Clostridium botulinum in continuous-fill, refrigerated, ready-to-eat soup products. FDA recommends an internal temperature of 194°F for at least 10 minutes to control the food safety hazard of Clostridium botulinum in continuous-fill, refrigerated, ready-to-eat soup products. If you choose to use other critical limits, you are responsible for scientifically establishing their adequacy.

  • Your HACCP plan does not list ,a critical limit at the "Cooling" critical control point for the time required for cooling to ensure that the food is not exposed to optimal temperatures for pathogen growth and toxin formation . FDA recommends the product should be cooled from 140°F (60°C) to 70°F (21°C) or below within two hours and to 40°F (4.4°C) or bel6w within another four hours.

4. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c) (4) . However, your HACCP plan lists a monitoring procedure/frequency at the [redacted] critical control point that is inadequate to control the food safety hazard of Clostridium botulinum in continuous-fill, refrigerated, ready-to-eat soup products. In addition to reviewing the continuous monitoring recording chart produced by the data recorder once per week, FDA recommends a visual check of the recording chart at least daily to ensure that the critical limit is met daily.

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 how you will correct these deviations. You should include in your response documentation such as revised HACCP plans, production or monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.

This letter may not list all the deviations at your facility . You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations.

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

Sincerely.
/s/

B. Belinda Collins
District Director