Company
United StatesIntegrated Ophthalmic Systems, Inc, Woburn, MA – FDA Inspections
Inspection records and compliance data for Integrated Ophthalmic Systems, Inc in Woburn, Massachusetts. 1 FDA inspection on record, last inspected December 15, 2021.
Company Profile
This profile covers Integrated Ophthalmic Systems, 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 December 15, 2021.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 15, 2021 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1158825 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Integrated Ophthalmic Systems, Inc
FEI Number
3016735536
Address
596 Main St, Woburn, Massachusetts 01801, United States
Country
United States
ID: 97ac1747-1ee5-4f0a-bbd0-5acd1dcbdcc1