FDA Inspection
Otodynamics LimitedOtodynamics Limited – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Otodynamics Limited, with an inspection on September 13, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 5b19f0ec-9852-4d64-9748-5a3255ec7f2c
Inspection Facts
- Inspection number
- 1065829
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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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 | |
| February 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Otodynamics Limited
- FDA Inspection 1261981 - 2025-01-09
- FDA Inspection 1003852 - 2017-02-03
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