FDA 483 - Sac, Llc - August 27, 2024

Sac, Llc, a medical device manufacturer in Sanford, FL, was inspected by the FDA from August 21-27, 2024. The inspection revealed significant deficiencies across multiple quality system areas, including complaint handling, corrective and preventive actions, nonconforming product control, document control, incoming product acceptance, and training. These observations indicate a systemic lack of adequately established and followed procedures.