FDA Inspection 670883 — ConvaTec, Inc
The FDA completed an inspection of ConvaTec, Inc on July 1, 2010 in Greensboro, NC. 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
- July 1, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Greensboro, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |