FDA Inspection 1019052 — IntroMedic Co., Ltd.
The FDA completed an inspection of IntroMedic Co., Ltd. on July 6, 2017 in Anyang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 6, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anyang (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |