FDA Inspection 1310166 - ESI Inc. - March 26, 2026

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Record Details

This FDA Inspection record concerns ESI Inc., with an inspection on March 26, 2026, issued by the Minneapolis District Office, covering medical devices & rad health.

Company: ESI Inc.
Inspection Date: March 26, 2026
Product Type: Medical Devices & Rad Health
Office: Minneapolis District Office

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ID · 8328d748-07a8-4061-96b5-4e12fae19fdf

Violation Codes8

ISO 13485:2016 Clause 4.2.3ISO 13485:2016 Clause 4.2.4ISO 13485:2016 Clause 7.3.1ISO 13485:2016 Clause 7.4.3ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.2.4ISO 13485:2016 Clause 8.3.1

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