Company
United StatesBreas Medical, Inc., North Billerica, MA – FDA Inspections
Inspection records and compliance data for Breas Medical, Inc. in North Billerica, Massachusetts. 5 FDA inspections on record, 1 Form 483, last inspected January 18, 2022.
Company Profile
This profile covers Breas Medical, Inc. based in North Billerica, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 2, 2015. Last inspected January 18, 2022.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 18, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1160697 |
| February 6, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1117048 |
| September 28, 2018 | Not classified | Medical Devices & Rad Health | 1120414 |
| November 25, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 957196 |
| October 2, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 950359 |
FDA documents
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Company Information
Name
Breas Medical, Inc.
FEI Number
3010817335
Address
16 Esquire Rd, North Billerica, Massachusetts 01862, United States
Country
United States
ID: 203fa837-ecb2-44c2-91d8-073b586f2670