FDA Inspection 919970 — Ascom (US) Inc.
The FDA completed an inspection of Ascom (US) Inc. on March 27, 2015 in Lakewood Ranch, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lakewood Ranch, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3175 | 21 CFR 820.186 | QSR |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |