Inspections, Compliance, Enforcement, and Criminal Investigations
Mason Brothers Co, 11/19/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142
November 19, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 10 - 04
Ric J. Harrison and Jeffrey C. Harrison
Mason Brothers Co.
P.O. Box 230
Wadena, Minnesota 56482-0230
Dear Messrs. Harrison:
We inspected your seafood processing facility located at 222 Fourth Street, Wadena, Minnesota, on July 7-8, 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 regulation for foods, Title 21, Code of Federal Regulations, Part 110 (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 Herring in Wine Sauce is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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.
Your significant violations were as follows:
1. 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). Your firm's HACCP plan for pickled herring lists a monitoring procedure/frequency at the receiving critical control point that is not adequate to control pathogen growth. Specifically, your HACCP plan lists that product surface temperature will be checked via infrared thermometer at the time the product is received. This monitoring procedure/frequency is inadequate because it is not consistent with the critical limits your firm has listed at this critical control point as "Ensure that ambient air temp is maintained at 40°F or less." Taking a one-time temperature of the product at delivery will not provide the ambient air temperature of the delivery vehicle during transit to your facility. In addition, this one time temperature of the product will not provide the "time" parameter that is necessary for your firm to implement corrective action at this critical control point. Your corrective action plan states, "Will base decision of rejection on time of excess temp."
We received a July 10, 2008, e-mail from Steve Weishair (copy enclosed), which states that your firm will "read the TTR" as the correction to this violation. We are unable to fully assess the adequacy of that correction because you did not provide enough detail about the time/temperature recorders (TTRs) and how you intend to use them to ensure that ambient temperature is maintained at or below 40°F during the transit period to your facility.
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 HACCP plan for pickled herring does not list the chemical food safety hazard of histamine formation at either of the critical control points, although this hazard was identified in your hazard analysis.
The July 10, 2008, e-mail from Steve Weishair states that the hazard has been added to the plan, however, you did not provide documentation to demonstrate the correction.
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.
You should respond in writing within 15 working days from your receipt of this Warning Letter. Please provide documentation of all corrective actions with your written response. Your response should outline the specific things you are doing to correct these violations, and you should include in your response documentation such as the revised HACCP plan, verification records, and 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 123) and the Current Good Manufacturing Practice regulation (21 CFR 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: Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have questions regarding any issues in this letter, please contact Mr. Philips at (612)758-7133.
W. Charles Becoat
Enclosure: E-mail, 7/10/08