FDA 483 - InVitroCare, Inc - August 03, 2023

InVitroCare, Inc. in Frederick, MD, was cited for significant deficiencies across its quality system during an FDA inspection. The firm lacked established procedures for design control, software validation, purchasing controls for suppliers, and numerous other critical quality system elements including nonconformance, CAPA, training, calibration, management review, and quality audits. These widespread issues indicate a fundamental failure to implement and maintain a compliant quality system for medical device manufacturing.