FDA 483 - CEP Bio-Coat, LLC - February 15, 2019

Orchid Orthopedic Solutions, LLC in Farmington Hills, MI, received a Form FDA 483 with seven observations, including repeat findings. The inspection revealed significant deficiencies in quality system procedures, particularly concerning nonconforming product control, CAPA implementation, process monitoring and validation, sampling plans, complaint handling, and quality audit practices. These issues indicate a systemic lack of robust quality management for medical device manufacturing.