FDA 483 - Medical Instrument Development Laboratories, Inc. - August 13, 2025

An FDA inspection of Medical Instrument Development Laboratories, Inc. in San Leandro, CA, revealed significant quality system deficiencies. The firm failed to adequately establish procedures for design input, corrective and preventive actions, complaint handling, and rework of nonconforming products. These issues were highlighted by recurring problems with their Vitreous Cutter device, including bent needles and inadequate investigations into product failures.