by ComplianceQuest

My Dashboard Inspection Tracker FDA Guidance Templates Assessments

Sign in Get started

Tracker Overview Enforcement Themes Form 483s Warning Letters Inspections Recalls Investigators Companies Facilities

ANALYTICS

Tracker Overview Enforcement Themes

FDA ACTIONS

Form 483s Warning Letters Inspections Recalls

AUDIT READINESS

COMPANIES

Companies Facilities

Loading…

Dashboard Warning LettersWarning Letter Details

Nipro Renal Solutions USA, Corporation Warning Letter Details

Warning Letter

Nipro Renal Solutions USA, Corporation

Nipro Renal Solutions USA, Corporation, 509 Fishing Creek Road Lewisberry , PA 17339 United States, (b)(6), (b)(7)(C)

Issue DateJuly 24, 2026

FEI NumberN/A

Violations2

CountryUnited States

Issuing Office

Center for Devices and Radiological Health

Product Type

Medical Devices

Status

Open

Subject

CGMP/QSR/Medical Devices/Adulterated

Nipro Renal Solutions USA, Corporation FDA Warning Letter, July 24, 2026