FDA Inspection
ISOVAC Products, LLCISOVAC Products, LLC – FDA Inspection, Feb 28, 2020
Record Details
This FDA Inspection record concerns ISOVAC Products, LLC, with an inspection on February 28, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ISOVAC Products, LLC
- Inspection Date
- February 28, 2020
- Product Type
- Devices
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ID · dff1078c-5e9a-4227-9f0f-7aaa23d62e6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1119235
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| May 11, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2021 | NAI | Center for Devices and Radiological Health | Compliance: 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 1205029 - 2023-05-11
- FDA Inspection 1155038 - 2021-08-26
- FDA Inspection 985971 - 2016-04-01
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