Company
United StatesOrthopedic Designs North America, Inc., Tampa, FL – FDA Inspections
Inspection records and compliance data for Orthopedic Designs North America, Inc. in Tampa, Florida. 4 FDA inspections on record, 1 Form 483, last inspected October 05, 2023.
Company Profile
This profile covers Orthopedic Designs North America, Inc. based in Tampa, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected June 8, 2011. Last inspected October 5, 2023.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Nonconforming product, Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 5, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1220268 |
| June 12, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1092720 |
| September 18, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 895589 |
| June 8, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 728487 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Orthopedic Designs North America, Inc.
FEI Number
3002684506
Address
5912 Breckenridge Pkwy Ste F, Tampa, Florida 33610, United States
Country
United States
ID: 5d12d0c4-2176-4aa0-8b96-d64701b804fa