FDA 483 - BioLyte Laboratories, LLC - December 18, 2019

BioLyte Laboratories, LLC in Grand Rapids, MI, was inspected and received a Form 483 with ten observations, many of which were repeat findings from a previous inspection. The inspection revealed significant deficiencies across quality control, training, production records, change control, product testing, supplier management, stability testing, data review, laboratory facilities, and equipment cleaning. These issues indicate a systemic lack of adherence to current Good Manufacturing Practices.