A. Cease manufacturing, processing, packing, labeling, holding, and/or distributing any article(s);
B. Submit additional reports or information to FDA;
C. Recall any article(s) at Defendants' expense; or
D. Take any other reasonable corrective action(s) as FDA, in its discretion, deems necessary to bring Defendants and their products into compliance with the Act, applicable regulations, and this Decree.
12. Any cessation of operations as described above shall continue until FDA notifies Defendants in writing that Defendants appear to be in compliance with the.Act and the requirements of this Decree, and that Defendants may resume operations. Such notification by FDA may not be unreasonably delayed.
13. Duly authorized representatives of FDA shall be permitted, without prior notice and as and when FDA deems necessary, to make inspections of Defendants' facilities and, without prior notice, take any other measures necessary to monitor and ensure continuing compliance with the terms of this Decree. During such inspections, FDA representatives shall be permitted prompt access to buildings, equipment, in-process and finished materials, containers, labeling and other materials therein; to take photographs and make video recordings; to take samples of Defendants' finished and unfinished materials and products, containers, labels, labeling, and other promotional materials; and to examine and copy all records relating to the receipt, manufacture, processing, packing, labeling, promoting, holding, and distribution of any and all Defendants' products in order to ensure continuing compliance with the terms of this Decree. The inspections shall be permitted upon presentation of a copy of this Decree and appropriate credentials. The inspection authority granted by this Decree is separate from, and in addition to, the authority to conduct inspections under the Act, 21 U.S.C. §374.
14. Defendants shall reimburse FDA for the costs of all FDA inspections, investigations, supervision, reviews, examinations, and analyses specified in this Decree or that FDA deems necessary to evaluate Defendants' compliance with this Decree. For the purposes of this Decree, inspections include FDA's review and
analysis of Defendants' claims for their products in the product labels, labeling, promotional materials, any and all websites owned or controlled by Defendants, and any and all websites referenced by, endorsed, or adopted directly or indirectly by Defendants that convey information about Defendants' products. The costs of such inspections shall be borne by Defendants at the prevailing rates in effect at the time the costs are incurred. As of the date that this Decree is signed by the parties, these rates are: $78.09 per hour and fraction thereof per representative for inspection work; $93.61 per hour or fraction thereof per representative for analytical or review work; $0,485 per mile for travel expenses by automobile; government rate or the equivalent for travel by air or other means; and the published government per diem rate or the equivalent for the areas in which the inspections are performed per-day, per-representative for subsistence expenses, where necessary. In the event that the standard rates applicable to FDA supervision of court-ordered compliance are modified, these rates shall be increased or decreased without further order of the Court.
15. Within ten (10) calendar days after the entry of this Decree, Defendants shall provide a copy of this Decree, by personal service or certified mail (restricted delivery, return receipt requested), to each and all of its directors, officers, agents, representatives, employees, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them (including "doing business as" entities) (hereafter collectively referred to as "associated persons"). Wthin thirty-five (35) calendar days of the date of entry of this Decree, Defendants shall provide to FDA an affidavit of compliance, stating the fact and manner of compliance with the provisions of this paragraph and identifying the names and positions of all associated persons who
have received a copy of this Decree and the manner of notification. In the event that Defendants become associated, at any time after the entry of this Decree, with new associated persons, Defendants shall: (a) within fifteen (15) calendar days of such association, provide a copy of this Decree to each such associated person by personal service or certified mail (restricted delivery, return receipt requested), and (b) on a quarterly basis, notify FDA in writing when, how, and to whom the Decree was provided.
16. Within ten (10) calendar days of entry of this Decree, Defendants shall post a copy of this Decree on a bulletin board in a common area at any of their manufacturing or distribution facilities, and shall ensure that the Decree remains posted for a period of twelve (12) months at each location.
17. Wthin ten (10) calendar days of entry of this Decree, Defendants shall provide FDA a list of all domain names and IP addresses they use to market or describe any product, regardless of whether such sites mention specific products Defendants sell. Defendants thereafter shall notify FDA within ten (10) days of any change to this list (either additions or deletions).
18. Defendants shall notify the District Director, FDA Detroit District Office, in writing at least fifteen (15) calendar days before any change in ownership, character, or name of its business, such as dissolution, assignment, or sale resulting in the emergence of a successor corporation, the creation or dissolution of subsidiaries, franchises, affiliates, or "doing business as" entities, or any other change in the corporate structure of Defendants Brownwood Acres or Cherry Capital, or in the sale or assignment of any business assets, such as buildings, equipment, or inventory, that may affect compliance with this Decree. Defendants shall provide a copy of this Decree to any potential successor or assignee at least fifteen (15) calendar days before any sale or assignment. Defendants shall furnish FDA with an affidavit of compliance with this paragraph no later than ten (10) calendar days prior to such assignment or change in ownership.
19. All notifications, certifications, reports, correspondence, and other communications to FDA required by this Decree shall be addressed to the Director, FDA Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207.
20. If Defendants fail to comply with any of the provisions of this Decree, including any time frame imposed by this Decree, then, on motion of the United States in this proceeding, Defendants Brownwood Acres and/or Cherry Capital shall pay to the United States of America the sum of one thousand dollars ($1,000) in liquidated damages per violation per day so long as such violation continues. For the purposes of this paragraph, a "violation" is defined as each time any Defendant introduces or delivers for introduction into interstate commerce any product that is accompanied by (on the product's label, labeling, promotional materials, websites owned or controlled by Defendants, or in any other media) a claim(s) that causes the product to be a drug or constitutes a health claim within the meaning of the Act, unless the product is an approved new drug or such claim is authorized by FDA.
21. Should the United States bring, and prevail in, a contempt action to enforce the terms of this Decree, Defendants shall, in addition to other remedies, reimburse the United States for its attorneys* fees, investigational expenses, expert witness fees, travel expenses incurred by attorneys and witnesses, and administrative court costs relating to such contempt proceedings.
B. Submit additional reports or information to FDA;
C. Recall any article(s) at Defendants' expense; or
D. Take any other reasonable corrective action(s) as FDA, in its discretion, deems necessary to bring Defendants and their products into compliance with the Act, applicable regulations, and this Decree.
13. Duly authorized representatives of FDA shall be permitted, without prior notice and as and when FDA deems necessary, to make inspections of Defendants' facilities and, without prior notice, take any other measures necessary to monitor and ensure continuing compliance with the terms of this Decree. During such inspections, FDA representatives shall be permitted prompt access to buildings, equipment, in-process and finished materials, containers, labeling and other materials therein; to take photographs and make video recordings; to take samples of Defendants' finished and unfinished materials and products, containers, labels, labeling, and other promotional materials; and to examine and copy all records relating to the receipt, manufacture, processing, packing, labeling, promoting, holding, and distribution of any and all Defendants' products in order to ensure continuing compliance with the terms of this Decree. The inspections shall be permitted upon presentation of a copy of this Decree and appropriate credentials. The inspection authority granted by this Decree is separate from, and in addition to, the authority to conduct inspections under the Act, 21 U.S.C. §374.
14. Defendants shall reimburse FDA for the costs of all FDA inspections, investigations, supervision, reviews, examinations, and analyses specified in this Decree or that FDA deems necessary to evaluate Defendants' compliance with this Decree. For the purposes of this Decree, inspections include FDA's review and
analysis of Defendants' claims for their products in the product labels, labeling, promotional materials, any and all websites owned or controlled by Defendants, and any and all websites referenced by, endorsed, or adopted directly or indirectly by Defendants that convey information about Defendants' products. The costs of such inspections shall be borne by Defendants at the prevailing rates in effect at the time the costs are incurred. As of the date that this Decree is signed by the parties, these rates are: $78.09 per hour and fraction thereof per representative for inspection work; $93.61 per hour or fraction thereof per representative for analytical or review work; $0,485 per mile for travel expenses by automobile; government rate or the equivalent for travel by air or other means; and the published government per diem rate or the equivalent for the areas in which the inspections are performed per-day, per-representative for subsistence expenses, where necessary. In the event that the standard rates applicable to FDA supervision of court-ordered compliance are modified, these rates shall be increased or decreased without further order of the Court.
15. Within ten (10) calendar days after the entry of this Decree, Defendants shall provide a copy of this Decree, by personal service or certified mail (restricted delivery, return receipt requested), to each and all of its directors, officers, agents, representatives, employees, successors, assigns, attorneys, and any and all persons in active concert or participation with any of them (including "doing business as" entities) (hereafter collectively referred to as "associated persons"). Wthin thirty-five (35) calendar days of the date of entry of this Decree, Defendants shall provide to FDA an affidavit of compliance, stating the fact and manner of compliance with the provisions of this paragraph and identifying the names and positions of all associated persons who
have received a copy of this Decree and the manner of notification. In the event that Defendants become associated, at any time after the entry of this Decree, with new associated persons, Defendants shall: (a) within fifteen (15) calendar days of such association, provide a copy of this Decree to each such associated person by personal service or certified mail (restricted delivery, return receipt requested), and (b) on a quarterly basis, notify FDA in writing when, how, and to whom the Decree was provided.
16. Within ten (10) calendar days of entry of this Decree, Defendants shall post a copy of this Decree on a bulletin board in a common area at any of their manufacturing or distribution facilities, and shall ensure that the Decree remains posted for a period of twelve (12) months at each location.
17. Wthin ten (10) calendar days of entry of this Decree, Defendants shall provide FDA a list of all domain names and IP addresses they use to market or describe any product, regardless of whether such sites mention specific products Defendants sell. Defendants thereafter shall notify FDA within ten (10) days of any change to this list (either additions or deletions).
18. Defendants shall notify the District Director, FDA Detroit District Office, in writing at least fifteen (15) calendar days before any change in ownership, character, or name of its business, such as dissolution, assignment, or sale resulting in the emergence of a successor corporation, the creation or dissolution of subsidiaries, franchises, affiliates, or "doing business as" entities, or any other change in the corporate structure of Defendants Brownwood Acres or Cherry Capital, or in the sale or assignment of any business assets, such as buildings, equipment, or inventory, that may affect compliance with this Decree. Defendants shall provide a copy of this Decree to any potential successor or assignee at least fifteen (15) calendar days before any sale or assignment. Defendants shall furnish FDA with an affidavit of compliance with this paragraph no later than ten (10) calendar days prior to such assignment or change in ownership.
19. All notifications, certifications, reports, correspondence, and other communications to FDA required by this Decree shall be addressed to the Director, FDA Detroit District Office, 300 River Place, Suite 5900, Detroit, Michigan 48207.
20. If Defendants fail to comply with any of the provisions of this Decree, including any time frame imposed by this Decree, then, on motion of the United States in this proceeding, Defendants Brownwood Acres and/or Cherry Capital shall pay to the United States of America the sum of one thousand dollars ($1,000) in liquidated damages per violation per day so long as such violation continues. For the purposes of this paragraph, a "violation" is defined as each time any Defendant introduces or delivers for introduction into interstate commerce any product that is accompanied by (on the product's label, labeling, promotional materials, websites owned or controlled by Defendants, or in any other media) a claim(s) that causes the product to be a drug or constitutes a health claim within the meaning of the Act, unless the product is an approved new drug or such claim is authorized by FDA.
21. Should the United States bring, and prevail in, a contempt action to enforce the terms of this Decree, Defendants shall, in addition to other remedies, reimburse the United States for its attorneys* fees, investigational expenses, expert witness fees, travel expenses incurred by attorneys and witnesses, and administrative court costs relating to such contempt proceedings.
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