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United States v. WA Heng Dou-FU & Soy Sauce Corp.

United States District Court, E.D. California

June 23, 2016

UNITED STATES OF AMERICA, Plaintiff,
v.
WA HENG DOU-FU & SOY SAUCE CORPORATION, a corporation, d/b/a WA HENG DOU-FU & SOY SAUCE INTERNATIONAL ENTERPRISES, and PENG XIANG

          PHILLIP A. TALBERT Acting United States Attorney COLLEEN M. KENNEDY Assistant United States Attorney BENJAMIN C. MIZER Principal Deputy Assistant Attorney General JONATHAN F. OLIN Deputy Assistant Attorney General MICHAEL S. BLUME Director, Consumer Protection Branch RAQUEL TOLEDO Trial Attorney, Consumer Protection Branch U.S. Department of Justice Attorneys for Plaintiff United States of America.

          CONSENT DECREE OF PERMANENT INJUNCTION

         Plaintiff, the United States of America, by its undersigned attorneys, having filed a Complaint for Permanent Injunction against Wa Heng Dou-Fu & Soy Sauce Corporation, a corporation, d/b/a Wa Heng Dou-Fu & Soy Sauce International Enterprises, and Peng Xiang "Martin" Lin, and Yuexiao "Opal" Lin, individuals (collectively "Defendants"), and Defendants, without admitting or denying the allegations in the Complaint, having appeared and consented to 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 all parties to this action.

         2. The Complaint states a cause of action against Defendants under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399f (the "Act").

         3. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 33 l(k), by causing articles of food, within the meaning of 21 U.S.C. § 321(f), to become adulterated, within the meaning of 21 U.S.C. § 342(a)(4), while such articles are held for sale after shipment of one or more components in interstate commerce.

         4. The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 33 l(k), by causing certain articles of food, within the meaning of 21 U.S.C. § 321(f), to become misbranded within the meaning of 21 U.S.C. §§ 343(e), (q), and/or (r), while such articles are held for sale after shipment of one or more of their components in interstate commerce.

         5. Upon entry of this Decree, Defendants and each and all of their directors, officers, agents, representatives, employees, attorneys, successors, assigns, and any and all persons or entities in active concert or participation with any of them (including individuals, partnerships, corporations, subsidiaries, and affiliates), who receive actual notice of this Decree (collectively, "Associated Persons"), are hereby permanently restrained and enjoined, under 21 U.S.C. § 332(a), and the inherent equitable authority of this Court, from directly or indirectly receiving, preparing, processing, manufacturing, labeling, packing, holding, and/or distributing any articles of food at or from 2451 26th Ave #1, Sacramento, California 95822-2269, or at or from any other locations at which Defendants, now or in the future, directly or indirectly receive, prepare, process, manufacture, label, pack, hold, and/or distribute any articles of food (collectively, "the facility"), including but not limited to 1305 Furneaux Road, Olivehurst CA 95961 (the "Furneaux Road Facility"), unless and until:

         A. Defendants retain, at their expense, an independent person or persons (the "Sanitation and Food Safety Expert(s)") who are without any personal or financial ties (other than the retention agreement) to Defendants or their families or operations, and who, by reason of background, education, training, or experience, are qualified to develop and implement a written sanitation and pathogen monitoring program in accordance with paragraph 5(B) below, to inspect Defendants' facility, and determine whether the methods, facilities, and controls are continuously operated and administered in conformity with this Decree, the Act, and its implementing regulations. Defendants shall notify FDA in writing of the name(s) and qualifications of the Sanitation and Food Safety Expert(s) as soon as they retain such expert(s);

         B. Defendants' Sanitation and Food Safety Expert(s), after reviewing all of FDA's observations from September 2011 to the present, prepare a written sanitation and pathogen monitoring program (the "Program"). Within seven (7) business days after the Sanitation and Food Safety Expert(s) finish writing the Program, Defendants shall submit the Program to FDA. The Program shall ensure that Defendants' manufacturing processes, cleaning and sanitizing operations, pest control, corrective actions, employee health and hygiene precautions, and facility construction and maintenance (including the facility's buildings and sanitation-related systems (e.g., plumbing, sewage disposal), equipment, and utensils contained therein) protect against the contamination of food and food-contact surfaces and prevent insanitary conditions at the facility to FDA's satisfaction and shall address, but not be limited to, the growth of microorganisms and the presence of filth. FDA shall endeavor to complete its review of the Program submitted to FDA by Defendants and provide written feedback to Defendants about the adequacy of the Program in a timely manner. The Program shall, at minimum:

i. Require cleaning and sanitizing of utensils, equipment, carts, and floors, as well as monitoring and recordkeeping of the same on a daily basis when operating;
ii. Verify the adequacy of daily cleaning and sanitizing using generalized microbial testing, such as aerobic plate count or adenosine triphosphate ("ATP") testing;
iii. Establish corrective actions for any positive findings that result from Defendants' generalized microbial testing, including the disposal of articles of food produced on food- contact surfaces that yielded positive findings, corrective actions to restore clean and sanitary conditions, and cleaning and sanitizing procedures to investigate the cause of any positive findings; and
iv. Establish monitoring and testing procedures to ensure that pathogenic organisms, including, but not limited to, Salmonella spp., are adequately controlled in the facility by, at a minimum, developing: (a) a schedule for regularly collecting swab samples from food-contact and non-food-contact surfaces, equipment, and other environmental sites throughout the facility where in-process and finished articles of food are received, processed, manufactured, prepared, packed, held, and/or distributed, and a facility map designating the locations for collecting swab samples; (b) a plan for testing all environmental samples for Salmonella spp.; (c) a plan for testing all environmental samples for Listeria spp., including Listeria monocytogenes; (d) a corrective action plan for responding to samples that yield pathogens; and (e) a plan to report the results of all positive test analyses conducted pursuant to this paragraph to FDA within two (2) calendar days of receiving such results and to retain all other test results conducted pursuant to this paragraph for FDA inspection;

         C. Ensure that Defendants comply with current good manufacturing practice ("cGMP") in manufacturing, packaging, or holding food, 21 C.F.R. Part 110;

         D. Establish a written employee training program that includes, at a minimum, instruction in sanitation control requirements for food handling and manufacturing, and documentation that each employee has received such training. Defendants' Sanitation and Food Safety Expert(s) shall confirm and record that each employee fully understands the substance of the employee training program;

         E. Defendants make the Program available and accessible to all their employees in a language each employee understands;

         F. Defendants assign responsibility and authority for implementing and monitoring the Program on a continuous basis to an employee who is trained in sanitation control requirements and qualified and authorized to implement and monitor the Program;

         G. The Sanitation and Food Safety Expert(s) conduct a comprehensive inspection of the facility and Defendants' methods and controls used to receive, prepare, process, manufacture, pack, hold, and distribute articles of food to determine whether Defendants have adequately established and implemented the Program, whether Defendants have adequately addressed the FDA investigators' inspectional observations listed on each Form FDA-483 issued to Defendants since September 2011, and whether Defendants comply with this Decree, the Act, and its implementing regulations, including the cGMP requirements for food;

         H. Within twenty (20) business days after the inspection described in paragraph 5(G) is completed, the Sanitation and Food Safety Expert(s) prepare and submit contemporaneously to FDA and Defendants, by courier service or overnight delivery service, a written report of the inspection, which shall include a list of any observed deviations from the Decree, the Act, and its implementing regulations, including, but not limited to, the cGMP requirements for food;

         I. Defendants notify FDA and the Sanitation and Food Safety Expert(s) in writing of the actions they have taken to correct each and all deviations listed in the ...


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