FDA 483 - Greenbrier International, Inc - October 05, 2021

Greenbrier International, Inc. in Chesapeake, VA, was inspected regarding its corporate office operations. The inspection revealed significant deficiencies in the firm's quality control unit, particularly concerning oversight of contract manufacturing organizations (CMOs) for OTC drug products. The firm lacked adequate written procedures for quality assurance, complaint handling, and employee training, indicating a systemic failure to ensure product quality and compliance with CGMP requirements.