FDA 483 - Hansen Ophthalmic Development Lab Inc - April 11, 2025

Hansen Ophthalmic Development Laboratory Inc. in Bellingham, WA, a manufacturer of Class II medical devices, was inspected and received a Form FDA-483 with ten observations. The inspection revealed severe deficiencies across its quality system, including a lack of established procedures for medical device reporting, design control, CAPA, complaint handling, purchasing controls, quality audits, and document control. The firm also failed to establish a design history file, adequately maintain device history records, and ensure UDI labeling requirements were met for its medical devices.