FDA Inspection
ORTHOPEDIATRICS CANADA ULCORTHOPEDIATRICS CANADA ULC – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns ORTHOPEDIATRICS CANADA ULC, with an inspection on March 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c55cf8fe-09eb-46e7-8733-b84629c5f36f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042676
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of ORTHOPEDIATRICS CANADA ULC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 31, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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