FDA Inspection 1308266 - Reprolife America, LLC - March 20, 2026

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Record Details

This FDA Inspection record concerns Reprolife America, LLC, with an inspection on March 20, 2026, issued by the Dallas District Office, covering medical devices & rad health.

Company: Reprolife America, LLC
Inspection Date: March 20, 2026
Product Type: Medical Devices & Rad Health
Office: Dallas District Office

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ID · 4cbb1488-385e-4858-8610-10d2ead22a4d

Violation Codes8

ISO 13485:2016 Clause 4.1.1ISO 13485:2016 Clause 4.2.3ISO 13485:2016 Clause 7.1ISO 13485:2016 Clause 7.3.10ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.5.2

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