CONSENT DECREE OF PERMANENT INJUNCTION
Plaintiff, the United States of America, by its undersigned attorneys, having filed a Complaint for permanent injunctive relief against Pierpont Seafood ("Pierpont"), Sovereign Seafoods, Inc., doing business as Harbor Meat & Seafood ("Sovereign"), and Alfred L. Ballabio (hereinafter, collectively, "defendants") and the defendants having appeared and having consented to the entry of this Consent Decree of Permanent Injunction ("Decree") without contest and before any testimony has been taken, and the United States of America having consented to this Decree;
IT IS HEREBY ORDERED, ADJUDGED AND DECREED that:
1. This Court has jurisdiction over the subject matter and over all parties to this action.
2. The Complaint for Permanent Injunction states a cause of action against the defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. ("the Act").
3. The defendants violate 21 U.S.C. § 331(k) of the Act by causing fish and fishery products, articles of food within the meaning of 21 U.S.C. § 321(f) (hereafter, "food"), to become adulterated within the meaning of 21 U.S.C. § 342(a)(4). The articles of food 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 been rendered injurious to health. Defendants Ballabio and Pierpont also violate the Act, 21 U.S.C. § 331(dd), by failing to register Pierpont in accordance with 21 U.S.C. § 350d and 21 C.F.R. Part 1, Subpart H.
4. The defendants and each and all of their agents, representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with any of them are hereby permanently restrained and enjoined, under the provisions of 21 U.S.C. § 332(a), from preparing, packing, holding, and distributing, at or from Pierpont's processing facility located at 1449 Spinnaker Drive, Ventura, California, Sovereign's processing facility located at 215 Helena Street, Santa Barbara, California, and at or from any other locations at which the defendants prepare, pack, hold, or distribute food, any fish or fishery products, unless and until:
A. The Pierpont facility has been registered in accordance with 21 U.S.C. § 350d and 21 C.F.R. Part 1, Subpart H, and FDA has been provided with written verification of such registration;
B. The defendants have selected a person ("expert") who is without any personal or financial ties (other than the consulting agreement) to the defendants or their families and who, by reason of background, experience, and education, is qualified to: (1) conduct hazard analyses and to develop adequate written hazard analysis critical control point ("HACCP") plans for the processing of fish and fishery products at Pierpont and Sovereign, as required by 21 C.F.R. § 123.6(a)-(c); (2) verify the adequacy of HACCP plans, as required by 21 C.F.R. § 123.8; (3) develop adequate Sanitation Standard Operating Procedures ("SSOPs") specific to Pierpont and Sovereign, as required by 21 C.F.R. § 123.11; and (4) evaluate the defendants' monitoring of key sanitation conditions and practices, as set forth in 21 C.F.R. § 123.11(b);
C. The expert selected by defendants has: (1) developed adequate, facility-specific, written HACCP plans for each type of fish and fishery product prepared, packed, held, and distributed by the defendants that will effectively control the hazards associated with each product, as required by 21 C.F.R. § 123.6; (2) evaluated the implementation of these plans to determine their adequacy, as required by 21 C.F.R. § 123.8; (3) developed adequate, facility-specific SSOPs for Pierpont and Sovereign, as required by 21 C.F.R. § 123.11; and (4) evaluated the defendants' monitoring of key sanitation conditions and practices, as set forth in 21 C.F.R. § 123.11(b);
D. The United States Food and Drug Administration ("FDA") has approved in writing the HACCP plans and SSOPs developed by the expert;
E. The defendants have implemented the HACCP plans to the satisfaction of FDA;
F. Within five (5) business days after receiving written notification from defendants that the requirements of paragraph 4(C) have been completed, or as soon thereafter as is reasonably practicable in the event that FDA representatives are attending to FDA matters that cannot be rescheduled, FDA, if it deems it necessary, shall inspect the defendants' processing facilities, including all records relating to the preparation, packing, holding, and distribution of fish and fishery products. The costs of FDA inspections conducted pursuant to this paragraph (including sampling, testing, travel, document preparation and review time, and subsistence expenses) shall be borne by the defendants at the rates specified in paragraph 14; and
G. FDA has notified the defendants, in writing, that they appear to be in compliance with all of the requirements specified in paragraph 4(A)-(F) of this Decree, the Act, and all applicable regulations.
H. The requirements set forth in paragraph 4 of this Decree do not prohibit the defendants from holding and distributing frozen fish and fishery products that are received and held by defendants in a frozen state, and that do not undergo any manipulation, including thawing, ...