FDA Inspection 702673 — Degania Medical Devices Pvt. Ltd.
The FDA completed an inspection of Degania Medical Devices Pvt. Ltd. on Jun 11, 2010 in Gurgaon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gurgaon (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |