FDA Inspection 994394 — CIBA VISION Johor Sdn. Bhd.
The FDA completed an inspection of CIBA VISION Johor Sdn. Bhd. on Nov 17, 2016 in Gelang Patah. 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
- Nov 17, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Gelang Patah (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |