FDA 483 - Micron Inc - December 19, 2025

Micron Inc, a contract testing laboratory in Wilmington, DE, received a Form 483 following an FDA inspection from December 15-19, 2025. The inspection revealed significant deficiencies in the firm's laboratory control procedures, specifically concerning the calibration and qualification of analytical instruments. Additionally, the Quality Unit failed to establish adequate written procedures for change control, indicating a lack of robust quality systems.