Company
United StatesSteris Corporation Hopkins Facility, Mentor, OH – FDA Inspections
Inspection records and compliance data for Steris Corporation Hopkins Facility in Mentor, Ohio. 4 FDA inspections on record (1 OAI), last inspected September 19, 2014.
Company Profile
This profile covers Steris Corporation Hopkins Facility based in Mentor, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected November 6, 2009. Last inspected September 19, 2014.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Contamination control, Lack of or inadequate procedures1 inspection
- Identification procedures, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 891424 |
| June 12, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 786100 |
| April 12, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 713862 |
| November 6, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 630421 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Steris Corporation Hopkins Facility
FEI Number
3000251274
Address
6515 Hopkins Rd, Mentor, Ohio 44060, United States
Country
United States
ID: bda59038-3a74-4e02-9bf4-d3a837e791d5