What happened
Original notice title
Nexagen, LLC 10/6/17
From the archived source record
Our inspection revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause dietary supplement products manufactured at your firm to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulations for dietary supplements found under 21 CFR Part 111. During the inspection, our FDA investigators observed the following significant violations of the CGMP regulations for dietary supplements: 1. Product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). e. Your response also stated that you will hire a GMP consultant to assist your quality control manager to establish product specifications and the appropriate policies in regards to the labels and packaging requirements, and that you intend to have the product specifications and policies completed and in place by the end of Q3 2017. In your response, you stated that you will hire a GMP consultant to assist in updating your MMRs. In your response, you stated that you will hire a GMP consultant to assist in updating your BPRs. In your response, you stated that you will work with a GMP consultant to create, document, and train staff on comprehensive returns and recall policy by the end of Q3 2017. In your response, you stated that you will work with a GMP consultant to create, document, and train staff on a comprehensive policy for product complaints by the end of Q3 2017.
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
- 0dc5fd764688
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 →