FDA Inspection 733859 — Medical Compression Systems DBN Ltd.
The FDA completed an inspection of Medical Compression Systems DBN Ltd. on June 23, 2011 in Or Akiva. 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
- June 23, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Or Akiva (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |