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483
•Micron Inc•December 19, 2025

Micron Inc – FDA 483, Dec 19, 2025

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)
View Company Profile

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

Other documents for Micron Inc
  • EIR - 2021-11-05November 5, 2021
  • 483 - 2021-11-05November 5, 2021

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