FDA Inspection 1028253 — Freespira, Inc.
The FDA completed an inspection of Freespira, Inc. on Oct 10, 2017 in Kirkland, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 10, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kirkland, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |