FDA Inspection 1330540 - Enterix, Inc. - August 10, 2026

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Record Details

This FDA Inspection record concerns Enterix, Inc., with an inspection on August 10, 2026, issued by the Center for Devices and Radiological Health, covering devices.

Company: Enterix, Inc.
Inspection Date: August 10, 2026
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b60400db-722e-4183-bbe6-ee3ae328d520

Violation Codes3

ISO 13485:2016 Clause 4.1.3ISO 13485:2016 Clause 8.2.1ISO 13485:2016 Clause 8.5.2

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