Company
United StatesSterigenics US, LLC, Hayward, CA – FDA Inspections
Inspection records and compliance data for Sterigenics US, LLC in Hayward, California. 9 FDA inspections on record, last inspected August 13, 2026.
Company Profile
This profile covers Sterigenics US, LLC based in Hayward, California, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 1
- NAI
- 7
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 2, 2009. Last inspected August 13, 2026.
Most cited issue areas
- In-process materials specifications1 inspection
- Test method modification records not maintained1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 13, 2026 | NAI | · Human Cellular, Tissue, and Gene Therapies | 1331328 |
| August 18, 2023 | Not classified | Medical Devices & Rad Health | 1215620 |
| April 4, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1009381 |
| September 7, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 986254 |
| May 5, 2015 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 925161 |
| April 12, 2013 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 826435 |
| August 9, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 794149 |
| June 7, 2012 | VAI | Biologics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 784882 |
| September 2, 2009 | NAI | Human Drugs · Drug Quality Assurance | 610603 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sterigenics US, LLC
FEI Number
3000215205
Address
2311 Lincoln Ave, Hayward, California 94545, United States
Country
United States
ID: 796c4730-28f0-4769-83d3-56e2fe1b4a3a