FDA Inspection
Orthoaccel Technologies, IncOrthoaccel Technologies, Inc – FDA Inspection, Feb 17, 2017
Record Details
This FDA Inspection record concerns Orthoaccel Technologies, Inc, with an inspection on February 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ffd9dbda-fec1-4fec-bf6c-a9dae1a2f612
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1020990
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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