What happened
Original notice title
Txsyn Int. LLC MARCS-CMS 677014, July 24, 2024
From the archived source record
Based on inspectional findings, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA regulations. Adulterated Dietary Supplements The inspection of your facility on October 25 through November 14, 2023 identified serious violations of the 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 supplements to be adulterated within the meaning of section 402(g)(1) of the Act [21 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. Your significant violations of the CGMP requirements are as follows: 1. For example, your "Inbound Policy" failed to provide written procedures regarding the examination of each immediate container or grouping of immediate containers in a shipment of product that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) for appropriate content label, container damage, or broken seals to determine whether the container condition may have resulted in contamination or deterioration of the received product, as required by 21 CFR 111.165(a). 3. In your response to this observation, dated January 16, 2024, you provided a blank “PACKAGING DESIGN CHECKLIST (poly, carton)” and a “Pre-Operation Procedure.” In another response dated January 16, 2024, you also provided a “Standard Operating Procedure (SOP) for GMP Clean Room: Repackaging of Bulk Products.” However, these documents do not cover all the applicable requirements of 21 CFR Part 111, Subpart L for written procedures for packaging and labeling operations.
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
- a9789ebbc347
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 →