FDA WARNING_LETTER - BioLyte Laboratories, LLC - December 18, 2019

The FDA inspected BioLyte Laboratories, LLC, from December 9-18, 2019, and February 13, 2020, identifying significant violations of CGMP regulations for finished pharmaceuticals and misbranding regulations for dietary supplements. The firm's drug products, including various silver, pain relief, and magnesium oil products, are deemed adulterated and unapproved new drugs, violating sections 501(a)(2)(B), 505(a), and 301(d) of the FD&C Act. They are also misbranded under section 502.

Key CGMP violations include: 1. Failure to perform adequate laboratory testing for identity and strength of active ingredients in each batch of drug product prior to release (21 CFR 211.165(a)). 2. Failure to conduct identity testing for each component of drug products and validate supplier test analyses (21 CFR 211.84(d)(1) and (2)). 3. Failure to establish a written stability testing program to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

The products are unapproved new drugs because they lack FDA approval and are not generally recognized as safe and effective (GRASE). Specifically, CBD and magnesium are not recognized active ingredients in applicable monographs or TFMs, and silver-containing