FDA Inspection
ZEPHYR SLEEP TECHNOLOGIES INC.ZEPHYR SLEEP TECHNOLOGIES INC. – FDA Inspection, Dec 8, 2015
Record Details
This FDA Inspection record concerns ZEPHYR SLEEP TECHNOLOGIES INC., with an inspection on December 8, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 8, 2015
- Product Type
- Devices
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ID · 7b71aa19-ffd5-4e3e-a4e2-da1113d2ce2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953840
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of ZEPHYR SLEEP TECHNOLOGIES INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2019 | Not classified | Office of Inspections and Investigations |
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