FDA Inspection
TP Orthodontics, Inc.TP Orthodontics, Inc. – FDA Inspection, Jun 28, 2019
Record Details
This FDA Inspection record concerns TP Orthodontics, Inc., with an inspection on June 28, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ef069290-23aa-4174-bfe9-7a5a77cb1fbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095870
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of TP Orthodontics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 19, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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