Company
CanadaZEPHYR SLEEP TECHNOLOGIES INC., Calgary, Canada – FDA Inspections
Inspection records and compliance data for ZEPHYR SLEEP TECHNOLOGIES INC. in Calgary. 2 FDA inspections on record, 1 Form 483, last inspected June 26, 2019.
Company Profile
This profile covers ZEPHYR SLEEP TECHNOLOGIES INC. based in Calgary, Canada.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 8, 2015. Last inspected June 26, 2019.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation acceptance criteria1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2019 | Not classified | Medical Devices & Rad Health | 1141388 |
| December 8, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 953840 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ZEPHYR SLEEP TECHNOLOGIES INC.
FEI Number
3008960597
Address
3553 31 St Nw Unit 306, Calgary, Canada
Country
Canada
ID: a33bb5bd-0207-4776-958c-7b22da0d9365