FDA 483 - RHYZ ANALYTICAL LABS - June 05, 2025

PHYZ ANALYTICAL LABS in Provo, UT, a contract laboratory, received an FDA Form 483 citing significant deficiencies in its quality control and manufacturing practices. Observations included inadequate investigations into out-of-specification microbial contamination in OTC drug products, a complete lack of written procedures for its quality control unit and laboratory operations, and insufficient cGMP training for employees. These issues indicate systemic failures in maintaining proper control over drug product quality and laboratory practices.