Company
United StatesHighland Breat Imaging, Penfield, NY – FDA Inspections
Inspection records and compliance data for Highland Breat Imaging in Penfield, NY. 6 FDA inspections on record, last inspected October 22, 2025.
Company Profile
This profile covers Highland Breat Imaging based in Penfield, NY, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 6
- Form 483s
- 0
- Warning letters
- 0
First inspected May 26, 2017. Last inspected October 22, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 22, 2025 | Not classified | Medical Devices & Rad Health | 1289758 |
| October 1, 2024 | Not classified | Medical Devices & Rad Health | 1251626 |
| October 19, 2023 | Not classified | Medical Devices & Rad Health | 1221482 |
| June 6, 2019 | Not classified | Medical Devices & Rad Health | 1093150 |
| May 9, 2018 | Not classified | Medical Devices & Rad Health | 1052554 |
| May 26, 2017 | Not classified | Medical Devices & Rad Health | 1012963 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Highland Breat Imaging
FEI Number
3009503044
Address
2212 Penfield Rd Ste 500, Penfield, NY 14526-1770, United States
Country
United States
ID: de0d8ad8-c114-466f-b6eb-e8d1f4a27052