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

FDA Inspection 1308266 for Reprolife America, LLC on March 20, 2026. Classification: N/A.

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Record Summary

FDA Inspection 1308266 for Reprolife America, LLC on March 20, 2026. Classification: N/A.

Violation Codes

ISO 13485:2016 Clause 4.1.1

ISO 13485:2016 Clause 4.2.3

ISO 13485:2016 Clause 7.1

ISO 13485:2016 Clause 7.3.10

ISO 13485:2016 Clause 7.3.9

ISO 13485:2016 Clause 7.5.6

ISO 13485:2016 Clause 8.2.2

ISO 13485:2016 Clause 8.5.2

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Record Information

Company

Reprolife America, LLC

Inspection Date

March 20, 2026

Product Type

Medical Devices & Rad Health

Office

Dallas District Office

ID: 93709139-205e-40f4-a3ae-bd2f9494cbca

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