Company
CanadaFocal Healthcare Inc., Toronto, Canada – FDA Inspections
Inspection records and compliance data for Focal Healthcare Inc. in Toronto. 2 FDA inspections on record, 2 Form 483s, last inspected September 26, 2018.
Company Profile
This profile covers Focal Healthcare Inc. based in Toronto, Canada.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected May 24, 2017. Last inspected September 26, 2018.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2018 | Not classified | Medical Devices & Rad Health | 1128931 |
| May 24, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1012058 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Focal Healthcare Inc.
FEI Number
3011853771
Address
10 Morrow Ave Unit 101, Toronto, Canada
Country
Canada
ID: 3f79d4cb-f3ee-4979-8fcf-0adcea15ed6c