FDA Inspection 1320072 - Guardian Medical USA Inc. - June 02, 2026

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Record Details

This FDA Inspection record concerns Guardian Medical USA Inc., with an inspection on June 2, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.

Company: Guardian Medical USA Inc.
Inspection Date: June 2, 2026
Product Type: Medical Devices & Rad Health
Office: Cincinnati District Office

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ID · a44c6b93-d379-4926-b794-ae36e87a1c2a

Violation Codes6

ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 7.3.8ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.3.1ISO 13485:2016 Clause 8.5.2

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