FDA Inspection 1063811 — Philosys Co. Ltd
The FDA completed an inspection of Philosys Co. Ltd on Aug 30, 2018 in Gunsan. 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
- Aug 30, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gunsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |