Company
United StatesNextPhase Medical Devices LLC, Mansfield, MA – FDA Inspections
Inspection records and compliance data for NextPhase Medical Devices LLC in Mansfield, Massachusetts. 7 FDA inspections on record, last inspected May 11, 2023.
Company Profile
This profile covers NextPhase Medical Devices LLC based in Mansfield, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected August 17, 2011. Last inspected May 11, 2023.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 11, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1205707 |
| June 24, 2022 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1173291 |
| May 7, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1142248 |
| December 13, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1112801 |
| April 24, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 828777 |
| September 26, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 746838 |
| August 17, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 740506 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
NextPhase Medical Devices LLC
FEI Number
3003174284
Address
110 Forbes Blvd, Mansfield, Massachusetts 02048, United States
Country
United States
ID: e561f5fc-9329-4bd9-a5e3-b260a5a0cc58