FDA 483 - BioLyte Laboratories, LLC - September 12, 2025

BioLyte Laboratories, LLC in Grand Rapids, MI, was cited with nine observations during an FDA inspection, indicating significant deficiencies across its quality control, manufacturing, and testing operations for OTC and homeopathic drug products. Key issues include inadequate investigations into out-of-specification results, unvalidated water systems and cleaning programs, and a lack of proper stability testing, raw material identity verification, and employee training. These findings suggest a systemic failure to adhere to cGMP requirements, posing a high risk to product quality and patient safety.