FDA Inspection 1097456 — First Call, Inc.
The FDA completed an inspection of First Call, Inc. on July 19, 2019 in Winona Lake, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Winona Lake, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |