Danmar Products, Inc. – FDA 483, Nov 4, 2024

Danmar Products, Inc. in Ann Arbor, MI, received a Form FDA 483 with seven observations following an inspection. The findings highlight significant deficiencies in the firm's quality system, including inadequate documentation for process validation, corrective and preventive actions, equipment maintenance, complaint handling, supplier evaluations, incoming product acceptance, and personnel training. Several of these observations were repeats from a previous inspection, indicating persistent issues.