Adler MicroMed, Inc. – FDA 483, Feb 12, 2026

An FDA inspection of Adler MicroMed, Inc., a manufacturer of Adler MicroMed Laser Surgery Fiber in San Diego, revealed significant deficiencies in their quality system. The firm failed to adequately monitor and control outsourced design and manufacturing processes, and lacked established criteria for supplier evaluation and selection. Additionally, verification activities for purchased sterile products were insufficient, particularly regarding sterility confirmation.