Company
United StatesISOVAC Products, LLC, Romeoville, IL – FDA Inspections
Inspection records and compliance data for ISOVAC Products, LLC in Romeoville, Illinois. 5 FDA inspections on record, 2 Form 483s, last inspected February 10, 2026.
Company Profile
This profile covers ISOVAC Products, LLC based in Romeoville, Illinois, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 1, 2016. Last inspected February 10, 2026.
Most cited issue areas
- Corrective action not taken1 inspection
- Design and development inputs not determined1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 10, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1302140 |
| May 11, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1205029 |
| August 26, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1155038 |
| February 28, 2020 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1119235 |
| April 1, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 985971 |
FDA documents
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Company Information
Name
ISOVAC Products, LLC
FEI Number
3006076009
Address
1306 Enterprise Dr Ste C, Romeoville, Illinois 60446, United States
Country
United States
ID: e76a5501-93ec-497f-8af4-92d23bb2e5f9