Company
United StatesSterigenics US LLC, Lewis Center, OH – FDA Inspections
Inspection records and compliance data for Sterigenics US LLC in Lewis Center, Ohio. 6 FDA inspections on record, 1 Form 483, last inspected May 28, 2025.
Company Profile
This profile covers Sterigenics US LLC based in Lewis Center, Ohio, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 19, 2009. Last inspected May 28, 2025.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 28, 2025 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 1271833 |
| June 22, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1173787 |
| April 26, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009920 |
| March 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 870254 |
| November 8, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 752268 |
| June 19, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 592377 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sterigenics US LLC
FEI Number
1526534
Address
305 Enterprise Dr, Lewis Center, Ohio 43035, United States
Country
United States
ID: f4af562c-3e9c-4625-a025-e3b64f17da40