FDA Inspection
Ototronix, LLCOtotronix, LLC – FDA Inspection, Aug 16, 2013
Record Details
This FDA Inspection record concerns Ototronix, LLC, with an inspection on August 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ototronix, LLC
- Inspection Date
- August 16, 2013
- Product Type
- Devices
View Company Profile
ID · 3e032e2b-08aa-47ea-887e-75173a67383c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842199
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Ototronix, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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