FDA Inspection
Tinnitus Control, Inc.Tinnitus Control, Inc. – FDA Inspection, Jun 19, 2009
Record Details
This FDA Inspection record concerns Tinnitus Control, Inc., with an inspection on June 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tinnitus Control, Inc.
- Inspection Date
- June 19, 2009
- Product Type
- Devices
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ID · bd55eaf4-230d-45ab-946b-3f0d4a5fba6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 590452
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.100(a)(1)Procedure for analysis of data sources
- 21 CFR 803.17Lack of Written MDR Procedures
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