651132
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |