FDA Inspection 1324522 — Creodent Hudson Valley
The FDA completed an inspection of Creodent Hudson Valley on Jul 23, 2026 in Fishkill, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fishkill, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23194 | ISO 13485:2016 Clause 7.6(a) | Measuring equipment not adequately calibrated or verified |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |