FDA Inspection 1313620 - Astura Medical - April 23, 2026

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Record Details

This FDA Inspection record concerns Astura Medical, with an inspection on April 23, 2026, issued by the Dallas District Office, covering medical devices & rad health.

Company: Astura Medical
Inspection Date: April 23, 2026
Product Type: Medical Devices & Rad Health
Office: Dallas District Office

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ID · d0973835-9543-4d16-9d15-ae0b2d5be028

Violation Codes5

ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.2.1ISO 13485:2016 Clause 8.2.2

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