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  5. Michigan Brands, Inc. - 08/07/2014
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Michigan Brands, Inc.

Michigan Brands, Inc.

United States

Issuing Office:
Detroit District Office

United States


Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393·81 00
FAX: 313-393·8139 


August 7, 2014
Mr. Michael J. Grillo,  Owner/President
Michigan Brands, Inc.
1313 S. Farragut Street
Bay City, Michigan 48708
Dear Mr. Michael J. Grillo:
The United States Food and Drug Administration (FDA) inspected your smoked seafood processing facility, Michigan Brands, Inc., located at 1313 S. Farragut Street, Bay City, Michigan, on June 17, 2014, through July 1, 2014.  During that inspection, FDA found that your facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. 
We acknowledge receipt of your response sent on July 16, 2014, which included a short summary of corrections to the observations noted on the FDA-483 as well as example documents with your firm identified on the records. Your response is inadequate in that you did not provide any updated or new HACCP Plan documentation to verify corrections.
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 Smoked Alligator, Salmon Smoked Strips, and Salmon Smoked Fillet products are adulterated, in that they have been prepared, packed, or held under unsanitary 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 conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you process 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). However, your firm has not conducted a hazard analysis and does not have a HACCP plan for Smoked Alligator and Salmon Smoked Strips to control the food safety hazard of Clostridium botulinum, pathogenic bacteria growth and toxin formation, and allergens. Both of these products are hot smoked, vacuum packed and labeled as “Keep Refrigerated.”
We acknowledge that you have a HACCP plan for Smoked & Smoke –Flavored Fishery Products dated 11-10-13 to cover the Salmon Fillet process, see observations 2-5 listed below. In accordance with 21 CFR 123.6(b)(2), firms may group kinds of fish and fishery products together, or group kinds of production methods together in one plan, only if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed are identical for all fish and fishery products so grouped or for all production methods so grouped. However, the Salmon Fillet process is a different process from the smoked alligator and salmon smoked strips. 
2.   You must conduct a hazard analysis 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 critical control points to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s “Smoked & Smoke-Flavored Fishery Products” HACCP plan for vacuum packaged, hot smoked salmon fillets does not list the critical control point of drying to control the identified hazard of Clostridium botulinum formation. 
Furthermore, your HACCP plan fails to include finished product labeling as a critical control point that is necessary to control the food safety hazard of undeclared allergens.
3.   You must have a HACCP plan that lists the food safety hazards that are reasonably likely to occur as required by 21 CFR 123.6 (c)(l ).  However, your HACCP plan for “Smoked & Smoke-Flavored Fishery Products” does not list the food safety hazards of pathogenic bacteria growth and toxin formation, and the undeclared allergen hazard associated with the “Salmon Smoked Fillets”. These items are processed, stored and distributed by your firm.  
4.   You must have a HACCP plan that, at a minimum, lists the critical limits that must be met to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s “Smoked & Smoke-Flavored Fishery Products”  HACCP plan for vacuum packaged, hot smoked Salmon Fillets does not list a critical limit at the “CCP #1 Formulation” critical control point that is adequate to control Clostridium botulinum germination, growth, and toxin formation. Specifically, your plan lists a critical limit of “Brine Strength Brine/fish ratio Brining period” and monitoring procedures/Frequencies/Person Responsible of  “Salometer reading to be at or above (b)(4).”
FDA recommends critical limits that may include: brine strength; brine to fish ratio; brining time; brining temperature; thickness; and drying time. Alternatively, if using nitrites, the water phase salt and nitrite level in the fished product may be included as a critical limit. The finished product should have not less than 3.5% wps or, where permitted, the combination of 3% wps and not less than 100 ppm nitrite. According to your “Fish Brine Records”, you are recording strength, gallons of brine, pounds of fish, time in the brine, and time out of the brine. Additionally, during the inspection it was noted that the brine temperature is not monitored and that only the cooler temperature is recorded (b)(4). This is inadequate to control Clostridium botulinum germination, growth, and toxin formation.
We also note your firm’s HACCP plan lists verification at the “brining” critical control point that you will conduct (b)(4) testing for water phase salt (WPS) to achieve a value of 3.5%. However (b)(4) testing does not ensure that each batch of fish achieves an adequate WPS level. For example the “CCP#1 Formulation” critical control point or the processing parameters list a WPS for the end product. This should be defined as a critical limit value that will result from the processing parameters in the HACCP plan or as an end product result to be verified in the verification procedures.
For additional information and guidance please see Chapter 13 of the Fish and Fishery Products Hazards Control Guidance.
5.   You must implement the monitoring and recordkeeping procedures listed in your “Smoked & Smoke-Flavored Fishery Products” HACCP plan for vacuum packaged, hot smoked Salmon Fillets to comply with 21 CFR 123.6(b). Specifically, you are not recording/documenting the “Salometer reading to be at or (b)(4)” on your formulation chart, “Fish Brine Records”, when you brined, hot smoked, and vacuum-packed salmon fillets on 3/20/14 and 5/28/14. This is evidenced by our review of the FDA cook chart records dated 3/20/14 and 5/28/14. 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Seafood HACCP regulation and the 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.
You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.   You should respond in writing within fifteen (15) working days from your receipt of this letter. 
Your response should outline the specific actions you are taking 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.
Additionally, 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-related 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.
Please send your reply to the Food and Drug Administration, Attention: Kelli Wilkinson, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207.  If you have any questions regarding this letter and /or information related to this case please contact me at (313) 393-8120 or via email at kelli.wilkinson@fda.hhs.gov
Paige E. Shelborne
Acting District Director                      
Detroit District Office
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