FDA Inspection
Applied Neuroscience, Inc.Applied Neuroscience, Inc. – FDA Inspection, Aug 5, 2010
Record Details
This FDA Inspection record concerns Applied Neuroscience, Inc., with an inspection on August 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Applied Neuroscience, Inc.
- Inspection Date
- August 5, 2010
- Product Type
- Devices
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ID · d9af68e4-ba8e-4917-81a2-0aea0a4a3a98
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 674751
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Applied Neuroscience, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2026 | Not classified | Florida District Office | Compliance: Medical Devices |
| April 11, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 19, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Applied Neuroscience, Inc.
- FDA Inspection 1308360 - 2026-03-03
- FDA Inspection 1166833 - 2022-04-11
- FDA Inspection 1018562 - 2017-07-19
- FDA Inspection 874551 - 2014-04-10
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