# Mirum Pharmaceuticals, Inc. – FDA 483, Jul 24, 2026

Source: https://www.keypedia.com/records/483/mirum-pharmaceuticals-inc/15d1e1fc-32ca-4510-b71b-772b8780247a

> FDA 483 for Mirum Pharmaceuticals, Inc. on July 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mirum Pharmaceuticals, Inc.
- Inspection Date: 2026-07-24
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: Mirum Pharmaceuticals, Inc. in Foster City, CA, was cited for failing to report serious and unexpected adverse drug experiences to the FDA within 15 calendar days. The inspection revealed inadequate oversight of their pharmacovigilance vendor, resulting in approximately 15% of expedited reports being submitted late over a two-year period. Furthermore, the firm lacked finalized deviations or CAPAs for several of these delayed submissions.

## Related Documents

- [EIR - 2021-05-12](https://www.keypedia.com/records/eir/mirum-pharmaceuticals-inc/2dbe9fa5-5534-4c76-800c-436943838c01) — date: May 12, 2021

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/mirum-pharmaceuticals-inc/9b906e94-ef88-467f-8b15-9f0b02d9e49d

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df