What happened
Original notice title
The Health Management Group Inc. MARCS-CMS 547614, June 06, 2018
From the archived source record
Based on our review, we have determined that your “AM/PM Weight Control Patches” is an unapproved new drug in violation of sections 505(a) and 301(d) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Based on our review, we have concluded that your products are misbranded under section 403 of the Act [21 U.S.C. § 343], and regulations implementing the dietary supplement labeling requirements of the Act, which are found in 21 CFR 101. Unapproved New Drug Your product “AM/PM FAT BURNING & APPETITE SUPPRESSING WEIGHT CONTROL PATCHES” is a drug under section 201(g)(1)(C) of the Act [21 U.S.C. § 321(g)(1)(C)], because it is an article (other than food) intended to affect the structure or any function of the body. Dietary Supplement CGMP Violations The December 28, 2017, to January 26, 2018, inspection of your facility revealed the following significant violation of the CGMP requirements for dietary supplements: You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act).
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 6d3937d2b498
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →