FDA Inspection
ISOVAC Products, LLCISOVAC Products, LLC – FDA Inspection, May 11, 2023
Record Details
This FDA Inspection record concerns ISOVAC Products, LLC, with an inspection on May 11, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5be9b053-8c8b-4864-93c0-53e48d9bccef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205029
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of ISOVAC Products, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2026 | Not classified | Chicago District Office | Postmarket Assurance: Medical Devices |
| August 26, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ISOVAC Products, LLC
- FDA Inspection 1302140 - 2026-02-10
- FDA Inspection 1155038 - 2021-08-26
- FDA Inspection 1119235 - 2020-02-28
- FDA Inspection 985971 - 2016-04-01
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