Company
CanadaPurdue Pharma, Pickering, Canada – FDA Inspections
Inspection records and compliance data for Purdue Pharma in Pickering. 5 FDA inspections on record, 1 Form 483, last inspected April 26, 2019.
Company Profile
This profile covers Purdue Pharma based in Pickering, Canada.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected July 15, 2011. Last inspected April 26, 2019.
Most cited issue areas
- SOPs not followed / documented2 inspections
- Absence of Written Procedures1 inspection
- Approval and review of procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 26, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1087591 |
| August 4, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1025638 |
| July 10, 2015 | VAI | Human Drugs · Drug Quality Assurance | 938743 |
| September 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 852516 |
| July 15, 2011 | VAI | Human Drugs · Drug Quality Assurance | 734736 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- Health Canada · 11 inspections · last June 19, 2023
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Purdue Pharma
FEI Number
3003287869
Canada Business Number
859442337RC0001
Address
575 Granite Crt, Pickering, Canada
Country
Canada
ID: 9f005c9c-c52f-4830-b544-bd991a18cc7c