FDA Inspection 1262841 - Saphena Medical, Inc. - March 04, 2025

FDA Inspection 1262841 for Saphena Medical, Inc. on March 04, 2025. Classification: Voluntary Action Indicated (VAI).

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Record Summary

FDA Inspection 1262841 for Saphena Medical, Inc. on March 04, 2025. Classification: Voluntary Action Indicated (VAI).

Violation Codes

21 CFR 803.50(a)(2)

21 CFR 820.100(a)

21 CFR 820.198(a)

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Record Information

Company

Saphena Medical, Inc.

Inspection Date

March 4, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

ID: fcfeec2c-f0a9-430a-a8ce-b142e7ecb546

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