FDA 483 - BioLyte Laboratories, LLC - April 24, 2023

An FDA inspection of BioLyte Laboratories, LLC in Grand Rapids, MI, revealed significant deficiencies in their manufacturing and quality control processes for drug products. The firm failed to conduct proper component identification, maintain an adequate stability program, and prevent objectionable microorganisms in non-sterile products. Additionally, the inspection cited issues with laboratory controls, the investigation of out-of-specification events, and the establishment of production and process controls.