FDA Inspection 1314396 - Pensar Medical LLC - April 28, 2026

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Record Details

This FDA Inspection record concerns Pensar Medical LLC, with an inspection on April 28, 2026, issued by the Dallas District Office, covering medical devices & rad health.

Company: Pensar Medical LLC
Inspection Date: April 28, 2026
Product Type: Medical Devices & Rad Health
Office: Dallas District Office

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ID · 7876621d-1798-481c-87c2-e9fb12c1a2ae

Violation Codes7

21 CFR 803.17(a)(1)ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 7.3.4ISO 13485:2016 Clause 7.3.6ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.5.2

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