Sanford Breast Health Institute, Sioux Falls, SD – FDA Inspections

Inspection records and compliance data for Sanford Breast Health Institute in Sioux Falls, SD. 7 FDA inspections on record, last inspected April 14, 2026.

Company Profile

This profile covers Sanford Breast Health Institute based in Sioux Falls, SD, United States.

FDA Inspection History

FDA inspections: 7
OAI: 0
VAI: 0
NAI: 0
Unclassified: 7
Form 483s: 0
Warning letters: 0

First inspected April 12, 2017. Last inspected April 14, 2026.

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
April 14, 2026	Not classified	Medical Devices & Rad Health	1313960
April 8, 2025	Not classified	Medical Devices & Rad Health	1267290
June 12, 2024	Not classified	Medical Devices & Rad Health	1241946
May 31, 2023	Not classified	Medical Devices & Rad Health	1207654
April 2, 2019	Not classified	Medical Devices & Rad Health	1086159
April 17, 2018	Not classified	Medical Devices & Rad Health	1049958
April 12, 2017	Not classified	Medical Devices & Rad Health	1007724

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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