FDA EIR - Micron Inc - November 05, 2021

An FDA surveillance inspection of Micron Inc., a contract analytical testing service provider for pharmaceutical and chemical companies in Wilmington, DE, was conducted from November 2-5, 2021. The inspection, carried out under Current Good Manufacturing Practices (CGMP) regulations governing human drug quality, identified significant deficiencies. The agency issued a 4-item FDA Form 483, highlighting critical violations. Key findings included the quality control unit's failure to establish and adhere to written procedures for analytical report reviews, specifically lacking verification against original source data. Audit trail functions on analytical instrument software, such as the FTIR, were not consistently enabled or reviewed, and calibration procedures for equipment like the DSC lacked complete instructions. Furthermore, employees lacked required annual GMP/GLP training and training for standard operating procedure revisions. Data integrity was compromised, with original data files on the FTIR instrument susceptible to deletion or modification, and the firm lacked defined remedial actions for failed data backups. Moreover, routine calibration of mechanical and electronic equipment was not consistently performed under a written program, evidenced by the absence of a formal calibration schedule and analytical balance calibrations failing to cover specified full use ranges. Micron Inc. management acknowledged these observations and committed to providing a written response to the FDA within 15 business days, outlining immediate corrective actions, including personnel adjustments and comprehensive procedural updates to address the identified compliance deficiencies.