FDA Inspection 1326218 - Bionix, Llc - July 14, 2026

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Record Details

This FDA Inspection record concerns Bionix, Llc, with an inspection on July 14, 2026, issued by the Cincinnati District Office.

Company: Bionix, Llc
Inspection Date: July 14, 2026
Office: Cincinnati District Office

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ID · ad55db32-1321-4c3a-bd98-7a3f64ab7c66

Violation Codes8

21 CFR 820.198(d)21 CFR 820.198(e)ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.3.6ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.4.3ISO 13485:2016 Clause 8.4

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