FDA Inspection 1327692 — AdDent, Inc.
The FDA completed an inspection of AdDent, Inc. on Jul 24, 2026 in Danbury, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Danbury, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23039 | ISO 13485:2016 Clause 4.2.4 | Document Control Procedure Inadequate |
| 23131 | ISO 13485:2016 Clause 7.3.9 | Significance of design and development changes not determined |
| 23140 | ISO 13485:2016 Clause 7.4.1 | Supplier evaluation and selection criteria do not include required elements |
| 23154 | ISO 13485:2016 Clause 7.4.3 | Records of purchased product verification not maintained |
| 23157 | ISO 13485:2016 Clause 7.5.1 | Medical device or batch records not adequate |