Company
United StatesTP Orthodontics, Inc., La Porte, IN – FDA Inspections
Inspection records and compliance data for TP Orthodontics, Inc. in La Porte, Indiana. 3 FDA inspections on record, 2 Form 483s, last inspected June 28, 2019.
Company Profile
This profile covers TP Orthodontics, Inc. based in La Porte, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected September 19, 2014. Last inspected June 28, 2019.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Nonconforming product control2 inspections
- Calibration procedures - content1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 28, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1095870 |
| April 9, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1048827 |
| September 19, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 898367 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
TP Orthodontics, Inc.
FEI Number
1815540
Address
100 Center Plz, La Porte, Indiana 46350, United States
Country
United States
ID: 45b48b23-a1bd-47b4-9770-6fe84412b53c