FDA 483 - Hanam International LLC - October 02, 2017

Hanam International LLC, a wholesale distributor and relabeler in Ridgefield, NJ, was cited for significant deficiencies in its quality system and material handling. The inspection revealed a complete absence of a quality control unit and written procedures for critical operations such as complaint handling, warehousing, and distribution. These issues indicate a fundamental lack of control over drug product quality and accountability.