Inspections, Compliance, Enforcement, and Criminal Investigations
Royal Foods, Inc. 23-Mar-06
Department of Health and Human Services
Public Health Service
Minneapolis District Office
March 23, 2006
RETURN RECEIPT REQUESTED
Refer to MIN 06 - 22
William J. Ferrell
Royal Foods, Inc.
325 Blake Road North
Hopkins, MN 55343-8298
Dear Mr. Ferrell:
We inspected your seafood processing facility located at 325 Blake Road North, Hopkins, Minnesota, on January 20 and 25, 2006. 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 ready-to-eat Seafood Salads 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 8v Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violation is as follows:
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 ready-to-eat Seafood Salads lists a monitoring frequency at the Receiving critical control point that is not adequate to control pathogen growth and toxin formation.
Specifically, your HACCP plan requires you to check the temperature of your product upon receipt. However, checking the temperature only at receipt leaves a gap of unknown quantity of hours during transport of these products. As many of these products are received from locations well outside the boundaries of the State, this is sufficient time for temperatures to fluctuate, rising sufficiently over an unmonitored and extended time period to allow for pathogen growth and toxin formation and also for dropping back down to a safe temperature before the receiving CCP check of the temperature. As such, the monitoring frequency currently employed by your firm is inadequate to control pathogen growth and toxin formation.
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 fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or 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.
For your information, we note that you utilize a third party monitoring system for your storage temperature monitoring. Ready-to-eat products require continuous temperature monitoring as they receive no heat treatment after storage. As you are not the party in control of this monitoring, we expect you to have full access to the continuous monitoring printouts and that these records, along with the alarm temperature set point and time period before activation, are regularly reviewed by your Seafood HACCP trained personnel and will be provided during our next inspection.
Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at(612) 758-7114.
W. Charles Becoat