Company
United StatesMed Pen Concepts, LLC, Woburn, MA – FDA Inspections
Inspection records and compliance data for Med Pen Concepts, LLC in Woburn, Massachusetts. 3 FDA inspections on record (2 OAI), 1 warning letter, last inspected January 24, 2024.
Company Profile
This profile covers Med Pen Concepts, LLC based in Woburn, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 2
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected April 13, 2022. Last inspected January 24, 2024.
Most cited issue areas
- Complaints2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 24, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1227633 |
| June 14, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1209069 |
| April 13, 2022 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1167029 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Med Pen Concepts, LLC
FEI Number
3015602723
Address
800 W Cummings Park Ste 5650, Woburn, Massachusetts 01801, United States
Country
United States
ID: e4eabde0-6259-49e5-933a-af195da882b7