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

FDA Inspection 1310166 for ESI Inc. on March 26, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1310166 for ESI Inc. on March 26, 2026. Classification: N/A.

Violation Codes

ISO 13485:2016 Clause 4.2.3

ISO 13485:2016 Clause 4.2.4

ISO 13485:2016 Clause 7.3.1

ISO 13485:2016 Clause 7.4.3

ISO 13485:2016 Clause 7.5.6

ISO 13485:2016 Clause 8.2.2

ISO 13485:2016 Clause 8.2.4

ISO 13485:2016 Clause 8.3.1

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Record Information

Company

ESI Inc.

Inspection Date

March 26, 2026

Product Type

Medical Devices & Rad Health

Office

Minneapolis District Office

ID: fb213400-95ad-4054-bd90-176131c35c4f

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