FDA Inspection 1311628 — HealthDent'l LLC
The FDA completed an inspection of HealthDent'l LLC on April 9, 2026 in Plainfield, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 9, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plainfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23189 | ISO 13485:2016 Clause 7.5.11 | Procedures for preserving the conformity of product not documented |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |