FDA Inspection 953840 — ZEPHYR SLEEP TECHNOLOGIES INC.
The FDA completed an inspection of ZEPHYR SLEEP TECHNOLOGIES INC. on Dec 8, 2015 in Calgary. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Calgary (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |