FDA 483 - The Procter & Gamble Company - August 23, 2022

The Procter & Gamble Company, a dietary supplement own label distributor, was cited for significant quality control deficiencies. These included a failure to establish and follow written procedures for material review and disposition decisions, particularly concerning product specifications and oversight of contract manufacturers. Additionally, the firm's quality control operations for product complaints lacked human review and approval for investigation decisions, especially for non-critical complaints.