FDA Inspection 1280338 - Nipro Renal Soultions USA, Corporation - March 27, 2026

Record Details

This FDA Inspection record concerns Nipro Renal Soultions USA, Corporation, with an inspection on March 27, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.

Company: Nipro Renal Soultions USA, Corporation
Inspection Date: March 27, 2026
Product Type: Medical Devices & Rad Health
Office: Philadelphia District Office

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ID · dfbb42e0-c3a1-43aa-a7a3-780a2348ee66

Violation Codes10

ISO 13485:2016 Clause 4.1.2ISO 13485:2016 Clause 4.2.3ISO 13485:2016 Clause 6.3ISO 13485:2016 Clause 7.3.10ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 7.4.1ISO 13485:2016 Clause 7.5.1ISO 13485:2016 Clause 7.5.6ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.2.4

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