FDA Inspection
Otodynamics LimitedOtodynamics Limited – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Otodynamics Limited, with an inspection on February 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e164e708-c8fe-4c0e-bd62-4491418b1276
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1003852
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Otodynamics Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2025 | Not classified | Office of Inspections and Investigations | |
| September 13, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
Other documents for Otodynamics Limited
- FDA Inspection 1261981 - 2025-01-09
- FDA Inspection 1065829 - 2018-09-13
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