FDA Inspection
Oto Med IncOto Med Inc – FDA Inspection, Aug 18, 2010
Record Details
This FDA Inspection record concerns Oto Med Inc, with an inspection on August 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oto Med Inc
- Inspection Date
- August 18, 2010
- Product Type
- Devices
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ID · 67ea0a02-fff4-4141-8c78-7fb55eeae314
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676486
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Oto Med Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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