FDA Inspection
Advanced Tactile Imaging, Inc.Advanced Tactile Imaging, Inc. – FDA Inspection, Dec 6, 2024
Record Details
This FDA Inspection record concerns Advanced Tactile Imaging, Inc., with an inspection on December 6, 2024, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- December 6, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 23bece95-f7ab-4b62-a449-663eead16bfa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258314
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advanced Tactile Imaging, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Advanced Tactile Imaging, Inc.
- FDA Inspection 1094611 - 2019-04-04
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