FDA Inspection 1307694 - Gentuity, LLC - March 05, 2026

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Record Details

This FDA Inspection record concerns Gentuity, LLC, with an inspection on March 5, 2026, issued by the New England District Office, covering medical devices & rad health.

Company: Gentuity, LLC
Inspection Date: March 5, 2026
Product Type: Medical Devices & Rad Health
Office: New England District Office

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ID · 4227b8c2-24cf-4f64-b5e3-6552554b8f5c

Violation Codes7

21 CFR 806.10(a)(1)ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.4.3ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.5.2

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