Company
United StatesOpgen, Inc., Woburn, MA – FDA Inspections
Inspection records and compliance data for Opgen, Inc. in Woburn, Massachusetts. 1 FDA inspection on record, last inspected November 19, 2015.
Company Profile
This profile covers Opgen, Inc. based in Woburn, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected November 19, 2015.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 19, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 954609 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Opgen, Inc.
FEI Number
3004080598
Address
400 Tradecenter Ste 6990, Woburn, Massachusetts 01801, United States
Country
United States
ID: 8129b6f8-abcd-4b9d-943e-e91ff50ee2b9