Company
United StatesOrthomerica Products, Inc., Orlando, FL – FDA Inspections
Inspection records and compliance data for Orthomerica Products, Inc. in Orlando, Florida. 3 FDA inspections on record, last inspected August 26, 2016.
Company Profile
This profile covers Orthomerica Products, Inc. based in Orlando, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 10, 2009. Last inspected August 26, 2016.
Most cited issue areas
- General1 inspection
- Lack of System for Determining MDR Events1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 26, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 985992 |
| May 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 830911 |
| September 10, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 611156 |
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
Orthomerica Products, Inc.
FEI Number
1000222089
Address
6333 N Orange Blossom Trl Ste 200, Orlando, Florida 32810, United States
Country
United States
ID: 17659eeb-6a5a-4d49-a7e0-d21b287a20f2