FDA Inspection 1310194 - Surgical Direct, Inc. - March 24, 2026

FDA Inspection 1310194 for Surgical Direct, Inc. on March 24, 2026. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1310194 for Surgical Direct, Inc. on March 24, 2026. Classification: Voluntary Action Indicated (VAI).

Violation Codes

ISO 13485:2016 Clause 4.1.6

ISO 13485:2016 Clause 5.6.1

ISO 13485:2016 Clause 7.1

ISO 13485:2016 Clause 7.5.4

ISO 13485:2016 Clause 8.2.2

ISO 13485:2016 Clause 8.2.4

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Record Information

Company

Surgical Direct, Inc.

Inspection Date

March 24, 2026

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fad411a0-1494-4f8c-a997-a3590adc42b0

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