Company
United StatesPrimrose Medical Inc., East Walpole, MA – FDA Inspections
Inspection records and compliance data for Primrose Medical Inc. in East Walpole, Massachusetts. 2 FDA inspections on record, last inspected October 26, 2022.
Company Profile
This profile covers Primrose Medical Inc. based in East Walpole, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 6, 2018. Last inspected October 26, 2022.
Most cited issue areas
- Design control - no procedures1 inspection
- Design history file1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 26, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1182299 |
| June 6, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1057152 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Primrose Medical Inc.
FEI Number
1220905
Address
286 Union St, East Walpole, Massachusetts 02032, United States
Country
United States
ID: 183a9d6e-b369-4fad-9cf6-a3f528b076a3