FDA Inspection 1201165 — Philosys Co. Ltd
The FDA completed an inspection of Philosys Co. Ltd on Mar 30, 2023 in Gunsan. 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
- Mar 30, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gunsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3175 | 21 CFR 820.186 | QSR |