FDA Inspection 1260164 — Poonglim Pharmatech Inc.
The FDA completed an inspection of Poonglim Pharmatech Inc. on Jan 16, 2025 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 16, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gunsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |