FDA Inspection 752359 — Kips Bay Medical Inc.
The FDA completed an inspection of Kips Bay Medical Inc. on Oct 19, 2011 in Minneapolis, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 19, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |