Company
United StatesIsomedix Operations Inc., Chester, NY – FDA Inspections
Inspection records and compliance data for Isomedix Operations Inc. in Chester, New York. 3 FDA inspections on record, last inspected February 21, 2025.
Company Profile
This profile covers Isomedix Operations Inc. based in Chester, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 7, 2019. Last inspected February 21, 2025.
Most cited issue areas
- Distribution records1 inspection
- Lack of or inadequate In-process acceptance procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 21, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1264291 |
| April 12, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1168479 |
| November 7, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1109042 |
FDA documents
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Company Information
Name
Isomedix Operations Inc.
FEI Number
3013820501
Address
2 Nucifora Blvd, Chester, New York 10918, United States
Country
United States
ID: 0c78fec2-88ae-46ae-b5c4-cecffb9fdc50