FDA 483 - Imagine Milling Technologies, LLC - February 01, 2023

Imagine Milling Technologies, LLC, a medical device manufacturer in Chantilly, VA, received a Form FDA-483 with a repeat observation during an inspection from January 30 to February 1, 2023. The firm failed to perform required quality audits, providing evidence only for a 2019 third-party audit and admitting no internal audits were conducted from 2020-2022. This indicates a significant and recurring lapse in their quality system oversight.