FDA Inspection 798340 — Drive DeVilbiss Healthcare
The FDA completed an inspection of Drive DeVilbiss Healthcare on August 31, 2012 in Canfield, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 31, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Canfield, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |