Isomedix Operations, Inc. dba Steris Applied Sterilization Technologies, Northborough, MA – FDA Inspections
Inspection records and compliance data for Isomedix Operations, Inc. dba Steris Applied Sterilization Technologies in Northborough, Massachusetts. 10 FDA inspections on record, last inspected August 01, 2025.
This profile covers Isomedix Operations, Inc. dba Steris Applied Sterilization Technologies based in Northborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 1
- NAI
- 8
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 29, 2010. Last inspected August 1, 2025.
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 1, 2025 | Not classified | Biologics, Human Drugs | 1273685 |
| March 9, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1122029 |
| December 12, 2018 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1076536 |
| April 19, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 968352 |
| January 21, 2015 | NAI | Human Drugs · Drug Quality Assurance | 915631 |
| April 9, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 874257 |
| December 20, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 861133 |
| January 4, 2013 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 812114 |
| October 19, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 750571 |
| October 29, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 695537 |
No Form 483s, Warning Letters or EIRs on record.
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Name
Isomedix Operations, Inc. dba Steris Applied Sterilization Technologies
FEI Number
1220477
Address
435 Whitney St, Northborough, Massachusetts 01532, United States
Country
United States
ID: 2144bb82-a91f-4be1-bf74-d0fa65adf263