Company
United StatesSterigenics US, LLC, Charlotte, NC – FDA Inspections
Inspection records and compliance data for Sterigenics US, LLC in Charlotte, North Carolina. 6 FDA inspections on record, last inspected June 26, 2025.
Company Profile
This profile covers Sterigenics US, LLC based in Charlotte, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 21, 2009. Last inspected June 26, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2025 | Not classified | Medical Devices & Rad Health | 1275509 |
| October 29, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1110767 |
| May 16, 2017 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 1020818 |
| October 30, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 855183 |
| August 11, 2011 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 744554 |
| August 21, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 608256 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sterigenics US, LLC
FEI Number
1000512168
Address
10821 Withers Cove Park Dr, Charlotte, North Carolina 28278, United States
Country
United States
ID: 299b6f87-556e-4ba0-8bf9-2827f6039355