Biosyntrx, Inc – FDA Warning Letter, Sep 5, 2014

The FDA conducted an inspection of Biosyntrx in Colorado Springs, CO, on September 4-5, 2014, finding serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). This caused products like BioTears, ZoOmega-3, and EpiCor to be adulterated.

Furthermore, FDA review of product brochures, price lists, and the website (biosyntrx.com) in February 2015 revealed that Biosyntrx's BioTears, Oculair, Macula Complete (now Eye & Body Complete), Sight C+, ZOmega-3, EpiCor, and Zeaxanthin-4 products are promoted with therapeutic claims, classifying them as unapproved new drugs under section 201(g)(1)(B) of the Act. These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval, violating sections 505(a) and 301(d). Additionally, some products are misbranded drugs under section 502(f)(1) due to inadequate directions for layperson use.

Specific CGMP violations include: 1. Failure to establish and follow written procedures for quality control operations, including material review and disposition (21 CFR 111.103, 111.140(b)). Biosyntrx did not review or approve finished