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United States v. Blanchet

United States District Court, C.D. California, Western Division

May 24, 2018

UNITED STATES OF AMERICA, Plaintiff,
v.
MICHEL G. BLANCHET, Defendant.

          MICHEL G. BLANCHET BRUCE J. GUTTMAN ATTORNEY FOR DEFENDANT

          MONICA C. GROAT TRIAL ATTORNEY FOR PLAINTIFF

          ROBERT P. CHARROW GENERAL COUNSEL REBECCA K. WOOD CHIEF COUNSEL FOOD AND DRUG DIVISION ANNAMARIE KEMPIC DEPUTY CHIEF COUNSEL, LITIGATION ROSELLE N. OBERSTEIN ASSOCIATE CHIEF COUNSEL FOR ENFORCEMENT

          Before the Honorable R. Gary Klausner, United States District Judge

          [PROPOSED] CONSENT DECREE OF PERMANENT INJUNCTION

          HONORABLE R. GARY KLAUSNER UNITED STATES DISTRICT JUDGE

         Plaintiff, the United States of America (the “United States”), by its undersigned attorneys, having filed a complaint for injunctive relief (the “Complaint”) against Michel G. Blanchet (“Defendant”), and Defendant having appeared, filed an answer, and consented to entry of this Consent Decree of Permanent Injunction (“Decree”) without contest and before any testimony has been taken, and solely for the purposes of settlement, and the United States having consented to this Decree;

         IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:

         1. This Court has jurisdiction over the subject matter and all parties to this action.

         2. The Complaint states a cause of action against Defendant under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (the “Act”).

         3. The Complaint alleges that Defendant violates the Act, 21 U.S.C. § 331(a), by causing to be introduced or delivered for introduction into interstate commerce food, within the meaning of 21 U.S.C. § 321(f), namely fish or fishery products, that are adulterated within the meaning of 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.

         4. The Complaint alleges that Defendant violates the Act, 21 U.S.C. § 331(k), by causing articles of food within the meaning of 21 U.S.C. § 321(f), namely fish or fishery products, to become adulterated within the meaning of 21 U.S.C. § 342(a)(4) while held for sale after shipment of one or more of its components in interstate commerce.

         5. Defendant represents that, as of the date of the entry of this Decree, he is not engaged in, either directly or indirectly, receiving, preparing, processing, packing, labeling, holding, and/or distributing fish or fishery products, nor is he causing the receipt, preparation, processing, packing, labeling, holding, and/or distribution of any fish or fishery products.

         6. “Defendant's Facility” is defined as any commercial location(s) at or from which Defendant, now or in the future, directly or indirectly receives, prepares, processes, packs, labels, holds, and/or distributes fish or fishery products.

         7. If Defendant intends to resume, either directly or indirectly, receiving, preparing, processing, packing, labeling, holding, and/or distributing fish or fishery products at or from Defendant's Facility, or causing any such activities at or from Defendant's Facility, he shall notify FDA in writing in advance of resuming any such activities. This notice shall identify the type(s) of fish or fishery products Defendant intends to receive, prepare, process, pack, label, hold, and/or distribute and his roles and responsibilities in such activities. In addition, if Defendant intends to resume, either directly or indirectly, receiving, preparing, processing, packing, labeling, holding, and/or distributing articles of fish or fishery products at or from Defendant's Facility, Defendant shall not resume any such activities until Defendant has complied with Paragraph 8(A)-(G) of this Decree, FDA has inspected Defendant's Facility pursuant to Paragraph 8(H) of this Decree, Defendant has paid the costs of such inspection(s) pursuant to Paragraph 8(I) of this Decree, and Defendant has received written notice from FDA, as required by Paragraph 8(J) of this Decree, and shall resume such activities only to the extent authorized in FDA's written notice.

         8. Upon entry of this Decree, Defendant and each and all of his officers, agents, employees, representatives, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) who received actual notice of this Decree by personal service or otherwise is hereby permanently restrained and enjoined, under the provisions of 21 U.S.C. § 332(a), and the inherent equitable authority of this Court, from directly or indirectly receiving, preparing, processing, packing, labeling, holding, and/or distributing fish or fishery products, at or from Defendant's Facility, unless and until:

         A. Defendant retains, at his expense, an independent person or persons (the “Expert” or “Experts”) having no personal or financial ties (other than the retention agreement) to Defendant or his family, and who, by reason of background, education, training, and experience, is qualified to assist Defendant in complying with the seafood Hazard Analysis Critical Control Point (“HACCP”) regulations, 21 C.F.R. Part 123. The Expert's seafood HACCP qualifications shall include, but not be limited to: developing procedures to adequately control for the risk of Listeria monocytogenes (“L. mono”) and C. botulinum (“C. bot.”) toxin formation in Defendants' seafood; developing adequate written Standard Sanitation Operating Procedures (“SSOPs”), as required by 21 C.F.R. § 123.11; establishing a Pathogen Control Program, pursuant to Paragraph 8(B)(4), for the genus Listeria (“L. spp.”); and developing and conducting employee training programs on sanitation and pathogen controls, and on complying with this Decree, the Act, and 21 C.F.R. Part 123. Defendant shall notify FDA in writing of the name(s) and qualifications of the Expert(s) under Paragraph 8(A) within five (5) calendar days of retaining such expert;

         B. The Expert(s), in conjunction with Defendant:

(1) Conducts hazard analyses for each type of fish and fishery product Defendant intends to process to identify all food safety hazards reasonably likely to occur, in accordance with 21 C.F.R. § 123.6(a);
(2) Develops and submits to FDA adequate written seafood HACCP plans, as explained in 21 C.F.R. Part 123, which include, for each food safety hazard reasonably likely to occur in each of Defendant's seafood products, critical control points, critical limits, and written corrective action plans addressing deviations from critical limits. Defendant's seafood HACCP plans must effectively control for all food safety hazards reasonably likely to occur for each type of fish and fishery product ...

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