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250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
March 16, 2017
Via UPS Overnight Delivery Refer to MIN 17 - 06
Roy E. Bolling
Owner and President
Day Fish Co., Inc.
4409 409th Avenue NW
Braham, Minnesota 55006-3519
Dear Mr. Bolling:
The Food and Drug Administration (FDA) conducted an inspection of Day Fish Co., Inc. located at 4409 409th Avenue NW, Braham, Minnesota, from January 17 to January 23, 2017. Our inspection determined your firm manufactures lutefisk from imported dried cod and distributes pickled herring cutlets.
The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 123. 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 refrigerated, ready-to-eat seafood products, such as your pickled herring products, 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.
Your significant seafood HACCP violations include the following:
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). Your firm does not have a HACCP plan for your pickled herring products to control food safety hazards which may include scombrotoxin (histamines) formation, pathogen growth, and allergens. In addition, the plastic containers holding the herring products allow for a reduced oxygen environment conducive to Clostridium botulinum growth and toxin formation as a result of time and temperature abuse.
Once you have created a HACCP plan for your pickled herring products, FDA recommends that you adequately monitor the processing and storage of your pickled herring products by continuously monitoring your processing and storage temperatures. During the inspection, we noted that you were not continuously monitoring the temperature for either the ready-to-eat herring or the lutefisk processing areas as required.
2. To comply with 21 CFR 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform the following functions: (1) the development of the HACCP plan, as required by 21 CFR 123.6(b); (2) the reassessment and modification of the HACCP plan in accordance with the corrective action procedures specified in 21 CFR 123.7(c)(5); (3) the reassessment and modification of the HACCP plan in accordance with the verification activities specified in 21 CFR 123.8(a)(1);
(4) the reassessment and modification of the hazard analysis in accordance with the verification activities specified in 21 CFR 123.8(c); and (5) perform the record review required by 21 CFR 123.8(a)(3).
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm does not have a sanitation or cleaning schedule, and is not routinely monitoring and maintaining sanitation records. Specifically, you could not demonstrate that you are monitoring the sanitation conditions and practices to assure conformance with Current Good Manufacturing Practices. During the inspection, we noted that you did not have sanitation records for the lutefisk manufacturing area and did not have records for monitoring pests from 2012 through 2017.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. In your response please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the corrections.
Please send your reply to the Food and Drug Administration, Attention: Boun M. Xiong, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact Mr. Xiong at (414) 326-3976.
Michael Dutcher, DVM