Company
United StatesPrimo Medical Group, Stoughton, MA – FDA Inspections
Inspection records and compliance data for Primo Medical Group in Stoughton, Massachusetts. 4 FDA inspections on record, last inspected October 03, 2019.
Company Profile
This profile covers Primo Medical Group based in Stoughton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected November 6, 2009. Last inspected October 3, 2019.
Most cited issue areas
- Documentation of validated process performance1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 3, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1105935 |
| July 27, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 940287 |
| February 18, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 711375 |
| November 6, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 627537 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Primo Medical Group
FEI Number
1000120613
Address
75 Mill St, Stoughton, Massachusetts 02072, United States
Country
United States
ID: 557abba5-c59a-42a3-9bf1-5b8a0a3d287f