FDA Inspection 545843 — CORIN MEDICAL, LTD.
The FDA completed an inspection of CORIN MEDICAL, LTD. on October 30, 2008 in Cirencester. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Cirencester (United Kingdom)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |