FDA Inspection 1249431 — Paragon Medical - Dayton
The FDA completed an inspection of Paragon Medical - Dayton on Sep 6, 2024 in Dayton, OH. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dayton, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3239 | 21 CFR 820.72(b) | Remedial action - documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |