Breast Care Center at Somerset Medical Center, Somerville, NJ – FDA Inspections

Inspection records and compliance data for Breast Care Center at Somerset Medical Center in Somerville, NJ. 6 FDA inspections on record, last inspected September 12, 2025.

Company Profile

This profile covers Breast Care Center at Somerset Medical Center based in Somerville, NJ, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 0
NAI: 0
Unclassified: 6
Form 483s: 0
Warning letters: 0

First inspected June 15, 2017. Last inspected September 12, 2025.

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
September 12, 2025	Not classified	Medical Devices & Rad Health	1283078
September 17, 2024	Not classified	Medical Devices & Rad Health	1250342
September 19, 2023	Not classified	Medical Devices & Rad Health	1219238
June 14, 2019	Not classified	Medical Devices & Rad Health	1094057
June 15, 2018	Not classified	Medical Devices & Rad Health	1056913
June 15, 2017	Not classified	Medical Devices & Rad Health	1015740

FDA documents

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

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