FDA Inspection 991211 — CLEMENT CLARKE INTL., LTD.
The FDA completed an inspection of CLEMENT CLARKE INTL., LTD. on Oct 13, 2016 in Mountain Ash. 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
- Oct 13, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mountain Ash (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |