FDA 483 - Myriad Fiber Imaging Technologies, Inc. - July 31, 2025

Myriad Fiber Imaging Technologies, Inc. in Dudley, MA, was inspected and received a Form 483 with two observations. The inspection revealed issues with production process controls, specifically a failure to follow established procedures for environmental conditions during device assembly. Additionally, the firm lacked established preventative maintenance schedules for critical production equipment.