FDA Inspection 1302140 - ISOVAC Products, LLC - February 10, 2026

FDA Inspection 1302140 for ISOVAC Products, LLC on February 10, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1302140 for ISOVAC Products, LLC on February 10, 2026. Classification: N/A.

Violation Codes

21 CFR 801.20(a)

21 CFR 830.300(a)

ISO 13485:2016 Clause 7.1

ISO 13485:2016 Clause 8.2.4

ISO 13485:2016 Clause 8.5.2

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Record Information

Company

ISOVAC Products, LLC

Inspection Date

February 10, 2026

Product Type

Medical Devices & Rad Health

Office

Chicago District Office

ID: fe751c77-9e34-468e-8d7f-849e7b458ac9

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