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U.S. Department of Health and Human Services

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Enforcement Actions

CFS Operating Limited dba Clouds Food Service Inc

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

November 12, 2009


2010-DAL-WL-02

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

David W. Floyd, President and Co-Owner
CFS Operating Limited d.b.a. Cloud's Food Service
1703 E. Whaley Street
Longview, Texas 75691
 

Dear Mr. Floyd:
 

We inspected your facility, located at 1703 East Whaley Street, Longview, Texas on June 29 through July 10, 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 (cGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Parts 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, 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 tuna salad sandwiches and other ready to eat sandwiches 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, the food cGMP 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 conduct or have conducted for you a hazard analysis for each kind of fish and fishery product you produce 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 CFR §123.6(a) and (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 tuna salad sandwiches does not list the food safety hazard of undeclared allergens and sulfites and the food safety hazard of Clostridium botulinum growth and toxin formation.
 

a. The tuna salad your firm uses to manufacture Tuna Salad Sandwiches includes the ingredients: tuna, sodium bisulfite, eggs, and soy flour. Further, your firm uses bread which includes the ingredients: wheat flour, soy lecithin, and milk. Some individuals are sensitive to sulfites. Fish, wheat, peanuts, soy, eggs milk, and tree nuts are the most common food allergens. HACCP plans for fishery products that contain these ingredients should list and control the hazards of undeclared sulfites and undeclared allergens. Chapter 19 of the Fish and Fisheries Products Hazards & Controls Guidance (the Guide) contains additional information regarding the control of these hazards.
 

b. Because your "Tuna Salad Sandwiches are packaged with an oxygen restrictive film (b)(4), FDA recommends that you implement a barrier to C. botulinum growth and toxin formation in conjunction with adequate refrigeration. Chapter 13 of the Guide lists guidance for controlling C. botulinum growth and toxin formation in vacuum packaged and reduced oxygen packaging.
 

2. 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 firm's HACCP plan for Tuna Salad Sandwiches lists critical limits, "Receipt temperature must be 41F or below" at the Receiving CCP and "Product temperature must not exceed 70°F for more than 3 hours cumulative time for all steps of the process," at three CCPs: "Storage in (b)(4) Cooler," "Production-Assemble Package Label Tuna Salad SandWich," and "Store in (b)(4) Cooler," that do not adequately control pathogen growth and histamine formation.
 

To properly control the food safety of pathogen growth and histamine formation, scombrotoxin-forming fish that have not been previously frozen should not be exposed to temperatures above 40F for more than 4 hours cumulatively if any portion of that time is a temperatures above 70°F. Your firm does not have information regarding previous storage temperatures of tuna included in the tuna salad therefore; you cannot ensure tuna has not been kept above 70°F.

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR § 123.6(c)(4). However, your firm's HACCP plan for Tuna Salad Sandwiches lists monitoring procedures/frequency, "Receipt temperature must be 41°F or below" at the "Receiving" critical control point that is not adequate to control the food safety hazards of pathogen growth and histamine formation. Firms that receive fishery products for which there is a pathogen and/or histamine hazard should ensure that the products they receive have been held at 40°F or less during transit. FDA recommends that you either require continuous temperature monitoring records or adequacy of ice as a condition of receipt.
 

Further, the inspection of your facility revealed deviations from the Current Good Manufacturing Practices (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110), in the production of your ready-to-eat sandwich products. The following conditions were documented:
 

4. Gloves used in food handling are not maintained in an intact, clean, and sanitary condition, 21 CFR § 110.10(b)(5). Our investigator observed an employee blow on her gloves and then handle pimento cheese sandwiches without further sanitizing her gloves.
 

5. Your firm did not handle and maintain equipment, containers, and utensils in a manner that protects against contamination, 21 CFR § 110.80(b)(7). Our investigator saw an employee lean a bare arm against the conveyor belt during the production of "Bologna and Cheese Sandwiches". In addition, an employee used a hose that had been left on a concrete slab outside the building during the cleaning of the meat slicer.
 

6. Effective measure are not being taken to exclude pests from the processing area and to protect against contamination of food on the premises by pests [21 CFR 110.35(c)]. Our investigator observed five dead insects and numerous insect parts inside the rear cooler, one flying insect in the production room and two dead in the washroom that opens directly into the production room.
 

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.

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 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response, documentation and 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.

Your reply should be directed to Sherrie L. Krolczyk, Compliance Officer, at the address indicated on the letterhead. If you have questions regarding any issues in this letter, please contact Sherrie L. Krolczyk at (214) 253-5312.
 

Sincerely,
/S/

Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

cc: Jay Dyer, Co-Owner
CFS Operating Limited d.b.a. Cloud's Food Service
1703 E. Whaley Street
Longview, Texas 75691
 

Jonathan Dyer, Co-Owner
CFS Operating Limited d.b.a. Cloud's Food Service
1703 E. Whaley Street
Longview, Texas 75691

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