# FDA 483 - Micron Inc - December 19, 2025

Source: https://www.keypedia.com/records/483/micron-inc/ae8e6fa4-0450-4049-b1df-1e2d87aec275

> FDA 483 for Micron Inc on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micron Inc
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Documents

- [483 - 2021-11-05](https://www.keypedia.com/records/483/micron-inc/eeb17597-ce96-4f8f-878b-f0527505ab35)
- [EIR - 2021-11-05](https://www.keypedia.com/records/eir/micron-inc/fb759594-1e32-486b-bf04-d84bf33086c5)

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)
- [investigator](https://www.keypedia.com/people/daniel-t-lee/8147e5b2-2065-42e3-b86c-36c0231f74cc)

Company: https://www.keypedia.com/companies/micron-inc/a65b7d60-a630-4106-a66e-0871c2852be4

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8