BALT USA, LLC – FDA 483, Jul 21, 2023

An FDA inspection of BALT USA, LLC in Irvine, CA, a manufacturer of Class II medical devices, revealed significant deficiencies in its quality system. The firm failed to timely report medical device malfunctions that could lead to serious injury or death, and also lacked proper documentation for corrective and preventive actions. Additionally, the acceptance status of subassembly lots was not adequately identified, indicating a systemic breakdown in quality control.