# FDA 483 - Micron Inc - November 05, 2021

Source: https://www.keypedia.com/records/483/micron-inc/eeb17597-ce96-4f8f-878b-f0527505ab35

> FDA 483 for Micron Inc on November 05, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micron Inc
- Inspection Date: 2021-11-05
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Documents

- [EIR - 2021-11-05](https://www.keypedia.com/records/eir/micron-inc/fb759594-1e32-486b-bf04-d84bf33086c5)
- [483 - 2025-12-19](https://www.keypedia.com/records/483/micron-inc/ae8e6fa4-0450-4049-b1df-1e2d87aec275)

## Related Officers

- [investigator](https://www.keypedia.com/people/lauren-n-barber/31610942-583f-4d3d-b870-077aead3e16f)
- [Junho Fak](https://www.keypedia.com/people/junho-fak/a878ece9-b952-4e1c-892b-689c0e8943ed)

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