FDA Inspection 874758 — ConvaTec, Inc
The FDA completed an inspection of ConvaTec, Inc on April 16, 2014 in Greensboro, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 16, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Greensboro, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |