FDA Inspection
ORTHOPEDIATRICS CANADA ULCORTHOPEDIATRICS CANADA ULC – FDA Inspection, Jul 25, 2013
Record Details
This FDA Inspection record concerns ORTHOPEDIATRICS CANADA ULC, with an inspection on July 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ORTHOPEDIATRICS CANADA ULC
- Inspection Date
- July 25, 2013
- Product Type
- Devices
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ID · ebc7ff21-45cf-499c-996b-01d66fa62994
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 845623
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ORTHOPEDIATRICS CANADA ULC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 31, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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