Company
CanadaSteris Applied Sterilization Technologies ULC, Whitby, Canada – FDA Inspections
Inspection records and compliance data for Steris Applied Sterilization Technologies ULC in Whitby. 7 FDA inspections on record, 1 Form 483, last inspected May 14, 2025.
Company Profile
This profile covers Steris Applied Sterilization Technologies ULC based in Whitby, Canada.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected April 30, 2009. Last inspected May 14, 2025.
Most cited issue areas
- Procedures not adequately established or maintained1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 14, 2025 | NAI | Human Drugs · Drug Quality Assurance | 1273126 |
| November 21, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1254759 |
| April 17, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1090677 |
| September 12, 2014 | NAI | Human Drugs · Drug Quality Assurance | 897808 |
| June 28, 2012 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 789382 |
| August 12, 2009 | NAI | Human Drugs · Drug Quality Assurance | 610911 |
| April 30, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 584628 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
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Company Information
Name
Steris Applied Sterilization Technologies ULC
FEI Number
3002807308
Canada Business Number
102540127
Address
184 Crown Crt, Whitby, Canada
Country
Canada
ID: acc4f194-51a2-4cab-aeb8-00e1f5bc1054