FDA Inspection 979210 — Richter Rubber Technology Sdn Bdh
The FDA completed an inspection of Richter Rubber Technology Sdn Bdh on Jun 2, 2016 in Kuala Ketil. 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
- Jun 2, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kuala Ketil (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |