United States of America v. Total Body Nutrition LLC et al
| United States of America |
| Total Body Nutrition LLC, TBN Labs LLC, Loud Muscle Science, LLC and Mohammed Islam |
| 2:2023cv09073 |
| December 11, 2023 |
| US District Court for the Eastern District of New York |
| Gary R Brown |
| Anne Y Shields |
| Other Statutory Actions |
| None |
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Filing 4
CONSENT DECREE ORDER OF PERMANENT INJUNCTION granting #3 Motion for Permanent Injunction: IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows: This Court has jurisdiction over the subject matter and all parties to this action pursuant to 21 U.S.C. 332 and its inherent equitable authority, and has personal jurisdiction over all parties to this action. Within thirty (30) calendar days of entry of the Decree, the CGMP Expert shall perform and complete a comprehensive in-person inspection of the Facility and the methods, processes, and controls used to receive, manufacture, prepare, process, pack, repack, label, hold, and/or distribute dietary supplements and certify in writing to FDA: (a) that he or she has inspected the Facility, methods, processes, and controls; (b) whether all deviations from Dietary Supplement CGMP that have been brought to Defendants' attention by FDA, the CGMP Expert, and any other source have been corrected; and (c) whether the Facility and the methods, processes, and controls used to receive, manufacture, prepare, process, pack, repack, label, hold, and/or distribute dietary supplements, are, in the COMP Expert's opinion, in compliance with this Decree, the Act, and its implementing regulations. The COMP Expert's report of the inspection shall be submitted to Defendants and FDA concurrently, within thirty (30) calendar days of completion of the inspection, and shall include, but not be limited to, a determination whether Defendants have created and implemented a system of methods, processes, and controls to ensure that they, at a minimum: SEE ATTACHED ORDER FOR FURTHER DETAILS. All notifications, correspondence, and communications to FDA required by the terms of this Decree shall be prominently marked "Consent Decree Correspondence" and addressed to Division Director, Office of Human and Animal Food Operations East New York District Office, U.S. Food and Drug Administration, 158-15 Liberty A venue, Jamaica, New York 11433, and via email at orahafeastlfirmresponses@fda.hhs.gov, and shall reference this civil action by case name and civil action number. No sooner than sixty (60) months after entry of this Decree, Defendants may petition FDA for leave to ask this Court for relief from this Decree. If, at the time of the petition, in FDA 's judgment, Defendants have maintained a state of continuous compliance with this Decree, the Act, and its implementing regulations for at least sixty (60) months, the United States will not oppose the petition, and Defendants may request the Court to grant such relief. So Ordered by Judge Gary R. Brown on 12/13/2023. (JC)
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| Filing 3 Letter MOTION for Permanent Injunction on behalf of all parties attaching Proposed Consent Decree of Permanent Injunction by United States of America (Attachments: #1 Proposed Judgment) (Blume, Michael) Modified on 12/15/2023 to edit to a motion(JC). |
| Filing 2 Clerk's Notice Re: Consent. A United States Magistrate Judge has been assigned to this case and is available to conduct all proceedings. In accordance with Rule 73 of the Federal Rules of Civil Procedure, Local Rule 73.1, the parties are notified that if all parties consent, the assigned Magistrate Judge is available to conduct all proceedings in this action including a (jury or nonjury) trial and to order the entry of a final judgment. Attached to this Notice is a blank copy of the consent form that should be filled out, signed and filed electronically only if all parties wish to consent. Any party may withhold its consent without adverse substantive consequences. Do NOT return or file the consent unless all parties have signed the consent.The form may also be accessed at the following link: #https://img.nyed.uscourts.gov/files/forms/MJConsentForm.pdf (DC) |
| Filing 1 COMPLAINT against All Defendants Was the Disclosure Statement on Civil Cover Sheet completed -No,, filed by United States of America. (Attachments: #1 Certificate of Service) (DC) (Attachment 1 replaced on 12/11/2023) (DC). |
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