FDA 483 - Blickman Industries LLC - March 21, 2025

Blickman Industries LLC in Lawrenceburg, TN, received a Form FDA-483 with three observations following an inspection. The firm demonstrated significant deficiencies in its quality system, specifically failing to adequately maintain and execute document control procedures for complaints, nonconformances, and supplier management. Additionally, the company lacked established procedures for final product acceptance activities and device history records.