King Brand Healthcare Products – FDA 483, Jul 24, 2026

An FDA inspection of King Brand Healthcare Products in Bellingham, WA, revealed significant deficiencies in their medical device quality system. The firm failed to adequately submit Medical Device Reports for devices experiencing serious malfunctions, lacked proper Unique Device Identification documentation, and did not maintain required design and development files or perform adequate design validation. Additionally, the company lacked written quality agreements for outsourced processes and failed to maintain equipment maintenance records, indicating systemic issues with their quality management.