Micron IncDecember 19, 2025

FDA 483 - Micron Inc - December 19, 2025

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Record Details

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.

Company: Micron Inc
Inspection Date: December 19, 2025
Product Type: Drugs
Office: Philadelphia District Office
People: David A. Oluwo (Pharmacy Intern/Certified Pharmacy Technician)
Daniel T. Lee (investigator)

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ID · ae8e6fa4-0450-4049-b1df-1e2d87aec275