Company
United StatesIsomedix Operations, Inc., Ontario, CA – FDA Inspections
Inspection records and compliance data for Isomedix Operations, Inc. in Ontario, California. 8 FDA inspections on record, last inspected December 11, 2024.
Company Profile
This profile covers Isomedix Operations, Inc. based in Ontario, California, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Unclassified
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected November 26, 2008. Last inspected December 11, 2024.
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2024 | Not classified | Biologics | 1257652 |
| June 24, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1107049 |
| December 14, 2016 | Not classified | Biologics | 1017556 |
| November 6, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 903956 |
| February 27, 2013 | NAI | Human Drugs · Drug Quality Assurance | 820631 |
| October 27, 2010 | NAI | Animal Drugs & Feeds, Biologics, Foods & Cosmetics, Medical Devices & Rad Health · Monitoring of Marketed Animal Drugs, Feed, and Devices | 695476 |
| July 29, 2009 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 600026 |
| November 26, 2008 | VAI | Foods & Cosmetics, Medical Devices & Rad Health · Compliance: Devices | 553028 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Isomedix Operations, Inc.
FEI Number
3003058448
Address
1000 Sarah Pl, Ontario, California 91761, United States
Country
United States
ID: 4e6ece98-421f-4d54-8d22-2d7e475bf749