Micron Inc – FDA 483, Nov 5, 2021

Micron Inc, a contract testing laboratory in Wilmington, DE, received a Form 483 with four observations highlighting significant deficiencies in its quality control unit, personnel training, data integrity, and equipment calibration. The firm lacked adequate written procedures for analytical data review and audit trails, failed to provide required GMP/GLP training, had insufficient electronic data security, and did not properly calibrate analytical equipment. These issues indicate a systemic breakdown in quality management practices.