FDA Inspection 1314736 — Praxis Powder Technology, Inc.
The FDA completed an inspection of Praxis Powder Technology, Inc. on April 30, 2026 in Queensbury, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Queensbury, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23077 | ISO 13485:2016 Clause 6.3 | Requirements for infrastructure maintenance activities not documented |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |