Company
CanadaCatalent Ontario Limited, Strathroy, Canada – FDA Inspections
Inspection records and compliance data for Catalent Ontario Limited in Strathroy. 4 FDA inspections on record, 2 Form 483s, last inspected May 02, 2025.
Company Profile
This profile covers Catalent Ontario Limited based in Strathroy, Canada.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 21, 2011. Last inspected May 2, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Complete instructions, procedures, specifications et. al.1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 2, 2025 | Not classified | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1268776 |
| April 12, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1090476 |
| November 7, 2014 | NAI | Human Drugs · Drug Quality Assurance | 906166 |
| September 21, 2011 | NAI | Human Drugs · Drug Quality Assurance | 748370 |
FDA documents
Form 483s (1)
Other regulators (1)
- Health Canada · 1 inspection · last March 25, 2019
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Catalent Ontario Limited
FEI Number
3007325436
Canada Business Number
134909902
Address
720 Wright St, Rr 7, Strathroy, Canada
Country
Canada
ID: 0d441910-9eee-4011-b5e8-c989fb788c69