Company
United StatesElite Orthopaedics Inc, South El Monte, CA – FDA Inspections
Inspection records and compliance data for Elite Orthopaedics Inc in South El Monte, California. 2 FDA inspections on record, last inspected April 29, 2015.
Company Profile
This profile covers Elite Orthopaedics Inc based in South El Monte, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 1, 2010. Last inspected April 29, 2015.
Most cited issue areas
- Lack of or inadequate organizational structure1 inspection
- Lack of Written MDR Procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 924123 |
| April 1, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 655382 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Elite Orthopaedics Inc
FEI Number
1000135616
Address
1535 Santa Anita Ave, South El Monte, California 91733, United States
Country
United States
ID: 9a51769a-fdb1-4cf3-ac10-461b74cd200a