FDA Inspection 573600 — Nipro Diabetes Systems, Inc.
The FDA completed an inspection of Nipro Diabetes Systems, Inc. on Mar 19, 2009 in Miramar, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2649 | 21 CFR 820.30(f) | Design verification acceptance criteria |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3675 | 21 CFR 820.30(f) | Design verification - unresolved discrepancies |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3701 | 21 CFR 820.250(a) | Techniques not used |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |