Company
United StatesMemorialCare Breast Center at Saddleback, Irvine, Irvine, CA – FDA Inspections
Inspection records and compliance data for MemorialCare Breast Center at Saddleback, Irvine in Irvine, CA. 6 FDA inspections on record, last inspected December 18, 2025.
Company Profile
This profile covers MemorialCare Breast Center at Saddleback, Irvine based in Irvine, CA, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected September 13, 2017. Last inspected December 18, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2025 | Not classified | Medical Devices & Rad Health | 1314712 |
| August 26, 2024 | Not classified | Medical Devices & Rad Health | 1248633 |
| September 12, 2023 | Not classified | Medical Devices & Rad Health | 1218466 |
| September 12, 2019 | Not classified | Medical Devices & Rad Health | 1104954 |
| September 11, 2018 | Not classified | Medical Devices & Rad Health | 1066404 |
| September 13, 2017 | Not classified | Medical Devices & Rad Health | 1026292 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Jennifer D. Keen-Kim, PhD
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Company Information
Name
MemorialCare Breast Center at Saddleback, Irvine
FEI Number
3012291157
Address
4040 Barranca Pkwy Ste 110, Irvine, CA 92604-4772, United States
Country
United States
ID: d6c81188-5929-417d-8632-105b5521cb34