Company
United StatesSteribite, LLC, Wooster, OH – FDA Inspections
Inspection records and compliance data for Steribite, LLC in Wooster, Ohio. 2 FDA inspections on record, 1 Form 483, last inspected April 08, 2026.
Company Profile
This profile covers Steribite, LLC based in Wooster, Ohio, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 21, 2017. Last inspected April 8, 2026.
Most cited issue areas
- Computer software used in production and service provision not validated1 inspection
- Design and development procedures not documented1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 8, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1312242 |
| December 21, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1040314 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Steribite, LLC
FEI Number
3009662229
Address
1877 Eagle Pass, Wooster, Ohio 44691, United States
Country
United States
ID: 9b9712b0-a831-486e-8b41-08f75e3b85d7