FDA Inspection 1312242 - Steribite, LLC - April 08, 2026

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Record Details

This FDA Inspection record concerns Steribite, LLC, with an inspection on April 8, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.

Company: Steribite, LLC
Inspection Date: April 8, 2026
Product Type: Medical Devices & Rad Health
Office: Cincinnati District Office

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ID · 43fa79d2-5eaa-4149-a08f-4a5bf488dbf3

Violation Codes10

21 CFR 830.300(a)ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 4.1.5ISO 13485:2016 Clause 4.2.3ISO 13485:2016 Clause 5.6.1ISO 13485:2016 Clause 6.2(e)ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.3.1ISO 13485:2016 Clause 7.5.1ISO 13485:2016 Clause 7.5.6

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