WARNING LETTER
Dixon Fisheries Inc MARCS-CMS 537106 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameJohn D. Dixon
- Dixon Fisheries Inc
1807 N. Main Street
East Peoria, IL 61611-2153
United States
- Issuing Office:
- Chicago District Office
United States
Chicago District Office | |
WARNING LETTER
FYI 8-HAFE6-01
October 24, 2017
VIA UPS
John D. Dixon, Owner
William R. Dixon, Sr., Owner
Dixon Fisheries, Inc.
1807 N. Main Street
East Peoria, IL 61611-2153
Dear John D. Dixon and William R. Dixon:
We inspected your seafood processing facility, located at 1807 N. Main Street, East Peoria, IL on August 8, 2017 through August 15, 2017. During the inspection 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. 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 cheesy crab spread and scallop and shrimp macaroni salad 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 in FDA's home page at www.fda.gov. You have not sent a formal response to the agency in regards to the FDA-483, Inspectional observations, issued to you on August 15, 2017.
Your significant violations are 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 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)(l). 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 plans for cheesy crab spread and scallop and shrimp macaroni salad do not list the food safety hazards of Clostridium botulinum growth and toxin formation and undeclared food allergens.
Your cheesy crab spread and scallop and shrimp macaroni salad products are placed into reduced oxygen packaging after processing. Clostridium botulinum toxin formation is reasonably likely as a hazard in products packed in reduced oxygen packaging materials and/or materials that are oxygen impermeable. For additional information related to the hazard of Clostridium botulinum, please refer to Chapter 13 of the Fish and Fishery Products Hazards and Control Guidance; 4th Edition.
Further, your cheesy crab spread contains the major food allergens milk, wheat, eggs, and fish. Yur scallop and shrimp macaroni salad contains the major food allergens wheat, eggs, and fish. Because major food allergens are a food safety hazard, it is recommended that they be included in your HACCP plan. Please refer to Chapter 19 of the Fish and Fishery Products Hazards and Control Guidance; 4th Edition for additional information on allergen controls.
2. 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 plans for cheesy crab spread and scallop and shrimp macaroni salad do not list monitoring frequencies at the thaw, preparation, and holding critical control points to control the hazard of bacterial growth and survival for the crab flakes, scallop and shrimp. FDA recommends that refrigeration temperatures be monitored and recorded continuously with a visual check of the monitoring device at least once per day.
3. As your firm 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 for cheesy crab spread and scallop and shrimp macaroni salad at the receiving, storage, thaw, preparation, and holding critical control points to control bacterial growth and survival are not appropriate. Your corrective actions do not ensure the cause of the deviation will be corrected.
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. Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has
been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31 (a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-relate costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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 a revised HACCP plan, along with
HACCP monitoring 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 and the seafood HACCP regulation (21 CFR 123). 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: Lauren Crivellone, 550 W. Jackson Blvd, Chicago, IL 60661. If you have questions regarding any issues in this letter, please contact Ms. Crivellone at (312) 596-4157 or via email at Lauren.Crivellone@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Division of Human and Animal Food
Operations Division 6 East