FDA Inspection 1267823 — Paragon 28, Inc.
The FDA completed an inspection of Paragon 28, Inc. on Apr 24, 2025 in Englewood, CO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 24, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Englewood, CO (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |