FDA Inspection 1247208 — IDS LTD
The FDA completed an inspection of IDS LTD on August 23, 2024 in Paju. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Paju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 5150 | 21 CFR 1040.10(f)(3) | Remote interlock connector |
| 5153 | 21 CFR 1040.10(f)(5)(ii) | Emission indicator - Class IIIb & IV |