Company
United StatesO. R. Surgical Company Inc., Greensboro, NC – FDA Inspections
Inspection records and compliance data for O. R. Surgical Company Inc. in Greensboro, North Carolina. 2 FDA inspections on record, 2 Form 483s, last inspected October 12, 2018.
Company Profile
This profile covers O. R. Surgical Company Inc. based in Greensboro, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 1, 2016. Last inspected October 12, 2018.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Lack of Written MDR Procedures2 inspections
- Management review - defined interval, sufficient frequency2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 12, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1068525 |
| November 1, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 993046 |
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
O. R. Surgical Company Inc.
FEI Number
1038524
Address
120 Montlieu Ave, Greensboro, North Carolina 27409, United States
Country
United States
ID: c3eb3bbd-486e-4740-8a81-bcb3c379bce1