Company
CanadaANI Pharmaceuticals Canada, Inc., Oakville, Canada – FDA Inspections
Inspection records and compliance data for ANI Pharmaceuticals Canada, Inc. in Oakville. 5 FDA inspections on record, 3 Form 483s, last inspected February 17, 2023.
Company Profile
This profile covers ANI Pharmaceuticals Canada, Inc. based in Oakville, Canada.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 0
First inspected December 18, 2009. Last inspected February 17, 2023.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Approve or reject components, products1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 17, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1197890 |
| June 7, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1096666 |
| December 9, 2016 | VAI | Human Drugs · Drug Quality Assurance | 997351 |
| January 24, 2014 | VAI | Human Drugs · Drug Quality Assurance | 866138 |
| December 18, 2009 | VAI | Human Drugs · Drug Quality Assurance | 635624 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- Health Canada · 6 inspections · last January 11, 2021
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Company Information
Name
ANI Pharmaceuticals Canada, Inc.
FEI Number
3002916530
Canada Business Number
816178529NS0002
Address
400 Iroquois Shore Rd, Oakville, Canada
Country
Canada
ID: 0f57ea01-9f34-4a4f-a2b9-4df6eb53a726