FDA 483 - Mkj Brands, Llc. - January 08, 2025

Mkj Brands, Llc., an importer and manufacturer in Hackensack, NJ, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to establish procedures for ensuring purchased products and services conform to requirements, specifically regarding the evaluation and control of a contract warehousing company for medical devices. Additionally, the inspection revealed a lack of established procedures for acceptance activities, including incoming inspection of imported devices.