Inspections, Compliance, Enforcement, and Criminal Investigations
Mackinac Straits Fish Company, Inc. 10/8/08
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
300 River Place
Detroit, MI 48207
RETURN RECEIPT REQUESTED
October 8, 2008
Jill W. Bentgen, President.
Mackinac Straits Fish Company, Inc.
109 West Elliott Street
Saint Ignace, Michigan 49781 -1869
Dear Ms. Bentgen:
We inspected your seafood processing facility, located at 109 West Elliott Street, St. Ignace, Michigan June 11-13, 2008. 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 vacuum packed smoked whitefish sausage and smoked freshwater fish fillet 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.
Your significant violations were as follows:
1. You must have a HACCP plan that, at a minimum, lists monitoring procedures/frequencies for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm's HACCP plan for vacuum packaged Smoked Whitefish Sausage lists monitoring procedures at the Cool and Store critical control points that are not adequate to control pathogen growth and Clostridium botulinum toxin formation. Specifically, the listed procedures are not designed to measure the critical limits listed in your HACCP plan.
2. You must immediately follow the procedures in 21 CFR 123.7 whenever any verification procedure reveals a need to take a corrective action, to comply with 21 CFR 123.8(6). However, your firm did not take "immediate" corrective actions when you deviated from your target water phase salt during the annual verification testing, and follow-up testing, of your refrigerated vacuum packaged Smoked Whitefish Sausage.
Furthermore, the corrective actions that you eventually took were not adequate to control Clostridium botulinum toxin formation. Specifically, you did not segregate and hold the affected products, perform or obtain a review to determine the acceptability of the affected product for distribution, or take corrective action, when necessary, with respect to the affected product to ensure that no product entered commerce that was either injurious to health or otherwise adulterated as a result of the deviation. In addition, the corrective action you initially took did not correct the cause of the deviation.
3. Since you chose to include corrective actions 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 vacuum packaged Smoked Whitefish Sausage at the Mix, Smoke, Cool, and Store critical control points to control Clostridium botulinum toxin formation and pathogen growth are not appropriate. Specifically, your corrective action plans at the Mix, Smoke, and Cool critical control points do not ensure that the cause of the deviation is corrected and your corrective action plans at the Cool and Store critical control points do not ensure that no product enters commerce that is injurious to health as a result of a deviation from the critical limits.
4. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, the target water phase salt of 3.0% listed in your HACCP plan for refrigerated vacuum packaged Smoked Whitefish Sausage is not adequate to verify the adequacy of your critical limits for controlling the food safety hazard of Clostridium botulinum toxin formation. FDA recommends a target water phase salt of 3.5 % for your product. Furthermore, FDA recommends a quarterly verification frequency for the salt analysis of your finished product.
We acknowledge receipt of your September 2, 2008 response letter to the inspectional observations issued at the conclusion of FDA's June 11 -12, 2008 inspection of your firm. We appreciate your firm's efforts in addressing the issues raised and the specific corrections your letter indicates you've made in order to comply with the Seafood HACCP Regulations. Your corrective actions will be further evaluated during our next inspection of your facility and your response will be filed as a part of the inspectional record for this facility.
Regarding your response to Observation #1, the corrective action you took in June of 2007 for the Lake Links with inadequate water phase salt levels, was to increase the salt level and retest until the levels reached an excess of 3.5%. However, you did not take corrective action regarding product in the market. The initial increase in salt proved to be insufficient to raise the water phase salt level to acceptable levels as evidenced by your follow-up testing. The increase in salt addition was not carried out by the operators as evidenced by the salt addition records. The use of salt addition tables may help the operators add the correct amount in the future; however, management should review the records to assure salt is added correctly.
Regarding your response to Observation #2, sanitation records require review because they include daily temperature monitoring of the coolers.
A cursory review of your HACCP Plan for Smoked Whitefish Sausage, revised June 12, 2008, finds that although you state in your latter that the formulation for the product provides for a water phase sale level of 3.5%, the plan still states in the product description as having a salt level of ≥ 3.0%. As noted in item #4 above, FDA recommends a target water phase salt level of 3.5% for your product. Also, your plan states the significant hazard being controlled by the addition of salt is "Pathogen growth", when the process step is more appropriately to control Clostridium botulinum.
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4) and the seafood HACCP regulation.
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 importer verification records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Judith A. Jankowski, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issue in this letter, please contact Ms. Jankowski at (313) 393-8125.
Joann M. Givens
Detroit District Office