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FDA Inspection
•Bionix, Llc•July 14, 2026

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, covering medical devices & rad health.

Company
Bionix, Llc
Inspection Date
July 14, 2026
Product Type
Medical Devices & Rad Health
Office
Cincinnati District Office
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ID · e6874ab6-4d74-4e0e-b4f2-94cf12046a80

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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