What happened
Original notice title
Adept Life Science, LLC MARCS-CMS 635400, January 24, 2023
From the archived source record
Based on the inspectional findings we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 United States Code (U.S.C.) § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. In addition, the (b)(4) brand (b)(4) and (b)(4) brand (b)(4) (in (b)(4) and (b)(4) sizes) dietary supplement products that you manufacture are misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. We address your response below, in relation to the applicable violations to which you responded. Dietary Supplement CGMP Violations Your significant violations of CGMP requirements are as follows: 1. Your (b)(4) brand (b)(4) and (b)(4) brand (b)(4) and (b)(4) sizes) products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Your (b)(4) brand (b)(4) ( (b)(4) and (b)(4) ) and (b)(4) brand (b)(4) ( (b)(4) and (b)(4) sizes) products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Your (b)(4) brand (b)(4) ( (b)(4) ) and (b)(4) brand (b)(4) ( (b)(4) and (b)(4) ) products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because the number of servings per container declared on the label is incorrect.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 2dba44126030
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 →