FDA 483 - Winder Laboratories, LLC - February 03, 2023

Winder Laboratories, LLC, a drug manufacturer in Winder, GA, received an FDA Form 483 citing significant deficiencies. The inspection revealed inadequate computer system controls and data integrity issues, including a lack of audit trail review and proper project folder management. Additionally, the firm failed to establish appropriate laboratory controls for elemental impurities and lacked sufficient written procedures for component testing and quality unit responsibilities.