Company
United StatesAdvanced Tactile Imaging, Inc., Ewing, NJ – FDA Inspections
Inspection records and compliance data for Advanced Tactile Imaging, Inc. in Ewing, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected December 06, 2024.
Company Profile
This profile covers Advanced Tactile Imaging, Inc. based in Ewing, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 4, 2019. Last inspected December 6, 2024.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 6, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1258314 |
| April 4, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1094611 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Advanced Tactile Imaging, Inc.
FEI Number
3011278898
Address
1457 Lower Ferry Rd, Ewing, New Jersey 08618, United States
Country
United States
ID: 5ff8ce1e-46ec-4a9b-b7dd-946b89f723e0