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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Willharvdoit Corporation 8/30/11

  

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN  55401
Telephone: (612) 334-4100
FAX: (612) 334-4142

August 30, 2011


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11 - 50


William P. Harvey
President/Owner
Willharvdoit Corporation
4706 West State Street
Milwaukee, Wisconsin  53208

Dear Mr. Harvey:

We inspected your seafood processing facility, located at 4706 West State Street, Milwaukee, Wisconsin, on May 10 to June 10, 2011.  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 regulation for foods (21 CFR 123 and 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 and fish patty 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 and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.

We acknowledge receipt of your response to the Form FDA-483 dated June 23, 2011, which included a description of your corrections, as well as a revised HACCP plan and supporting documentation. Review of the response revealed continued concerns that are addressed below.

Your most 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 that you produce to determine whether there are food safety hazards that 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). However, your firm does not have a HACCP plan for frozen ready-to-eat fish patty sandwiches to control the hazards of pathogen growth and undeclared allergens.

2. 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 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 revised HACCP plan submitted with your June 23, 2011, response entitled “Fully Cooked Ready-to-eat Fish Sandwiches,” which is intended to cover your tuna salad sandwiches does not list the food safety hazards of Clostridium botulinum growth and toxin formation, and histamine.  The plan lists various pathogens as hazards, however, the most likely hazards associated with your tuna salad sandwiches are Clostridium botulinum toxin formation and histamine formation because you are receiving (i.e., from a previous processor) and further processing the tuna salad as a ready-to-eat refrigerated product.   

With regard to the food safety hazard of Clostridium botulinum growth and toxin formation, we note that you receive your tuna salad in (b)(4) pound containers and your firm packages the final sandwich products in a heat-sealed wedge container that is oxygen impermeable. Both of these types of packaging do not provide a sufficient exchange of oxygen to allow aerobic spoilage organisms to grow and spoil the product before the toxin is produced when the products are exposed to moderately abusive temperatures.  Consequently, these products need a secondary barrier, in addition to refrigeration, to control toxin formation. FDA has several recommended strategies for secondary barriers, and one such strategy is control of the pH to a value of 5.0 or below. FDA collected samples of your raw material tuna and finished product sandwiches. The results of the pH determinations showed that the incoming raw material and the finished sandwich products all exhibited pH value slightly higher than 5.0 (i.e.,  between 5.2 and 5.88). We suggest that because your tuna is already somewhat reduced in pH that your firm adopt a strategy to control the pH to 5.0 or below. This may be done by conducting lot-by-lot testing of a representative sample of each lot of tuna salad received. This method allows you to set your temperature critical limits at 40°F. Another method of control is to affix time and temperature integrators (TTIs) to each finished sandwich package. This method requires temperature critical limits to be set at 38°F.  These control strategies, along with others, are further explained in Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance, 4th edition.

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 firm’s revised HACCP plan for tuna salad sandwiches submitted with your June 23, 2011, response fails to list a critical limit necessary to control pathogen growth and toxin formation (i.e., associated with the various pathogens listed in the plan) at the “Receiving Refrigerated Ingredients” critical control point. Because you are receiving product that is transported less than four hours in refrigerated trucks, FDA recommends that in addition to monitoring product temperatures you list a critical limit associated with transport time to ensure that transport times are less than four hours. The time element should include the time at which the product was first removed from a controlled temperature environment before shipment (i.e., at the shipper’s facility). Additionally, FDA currently recommends that processors monitor a minimum of 12 containers (or all containers for lots smaller than 12).
 
In addition, because infrared thermometers are referenced in your plan and are a thermometer that is primarily used on surfaces, your plan should indicate that you will be taking “surface” temperatures of the containers at receipt.

4. 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 revised HACCP plan for tuna salad sandwiches submitted with your June 23, 2011, response lists monitoring procedures at the “Finished Product Labeling” critical control point that are not adequate to control the identified hazard of “Presence of allergens in finished product.”  Specifically, your plan does not reference a comparison of the finished product labels with the product formula or ingredients declaration to ensure accuracy of the labeling.

5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans listed in your HACCP plan for your tuna salad sandwiches are not appropriate to control pathogen growth at the: 

o “Receiving Refrigerated Ingredients” critical control point, in that the listed corrective actions of (b)(4) cannot be implemented by your firm. The (b)(4) can not be determined based on (b)(4), which is listed as your monitoring procedure at (b)(4)(b)(4) can only be implemented with (b)(4). Your plan also fails to list correcting the cause of the deviation, such as “discontinue of supplier” or some other means to address proper correction to the cause of deviation.

o “Ingredient Cooler Storage Temperature” and “Finished Product Cooler Storage” critical control points, in that the corrective actions fail to list remedial actions to prevent further deterioration of the product (e.g., by adding ice or moving product to another cooler) and fail to address correcting the cause of the deviation such as repairing the coolers. 

We also acknowledge that in your response you state that you have corrected or are in the process of correcting the sanitation deficiencies. We are requesting that you provide a timeline for these corrections, particularly replacement of the processing belt. Corrections to the other sanitation deficiencies will be confirmed during our next inspection.

This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.

Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence.  If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.

Please send your reply to the Food and Drug Administration, Attention:
Tyra S. Wisecup, Compliance Officer, at the address on this letterhead.  If you have questions regarding the issues in this letter, please contact Ms. Wisecup at (612) 758-7114.

Sincerely,

/s/

Gerald J. Berg
Director
Minneapolis District