Company
CanadaAffinity Biologicals Inc., Ancaster, Canada – FDA Inspections
Inspection records and compliance data for Affinity Biologicals Inc. in Ancaster. 2 FDA inspections on record, 1 Form 483, last inspected June 14, 2018.
Company Profile
This profile covers Affinity Biologicals Inc. based in Ancaster, Canada.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected June 11, 2015. Last inspected June 14, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 14, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1056954 |
| June 11, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 929304 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Affinity Biologicals Inc.
FEI Number
3003485232
Address
1395 Sandhill Dr, Ss 108, Ancaster, Canada
Country
Canada
ID: 505782cd-495a-497a-8e35-b032339179fc