Company
United StatesOphthalMed LLC, Roswell, GA – FDA Inspections
Inspection records and compliance data for OphthalMed LLC in Roswell, Georgia. 3 FDA inspections on record, 1 Form 483, last inspected May 01, 2017.
Company Profile
This profile covers OphthalMed LLC based in Roswell, Georgia, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 2, 2011. Last inspected May 1, 2017.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Document locations, Dissemination, etc.1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1020101 |
| February 24, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 868674 |
| August 2, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 739449 |
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
OphthalMed LLC
FEI Number
3004497289
Address
1050 Northfield Ct Ste 280, Roswell, Georgia 30076, United States
Country
United States
ID: 453bb21e-f8be-4a90-820c-4a5741c80861