FDA Inspection 1022872 — Konica Minolta Healthcare, Americas, Inc.
The FDA completed an inspection of Konica Minolta Healthcare, Americas, Inc. on August 25, 2017 in Garner, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 25, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Garner, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |