FDA 483 - Nephron Pharmaceuticals - December 02, 2022

The FDA Form 483 inspection revealed significant deficiencies at the facility. A primary concern is the absence of a dedicated quality control unit, despite quality activities like retain examinations being performed by warehouse personnel.

The firm failed to visually examine reserve samples from drug product lots at least annually for deterioration, specifically lacking scientific justification for not inspecting vials packaged in secondary foil wrappers. The procedure SOP-SC-QA-3251, "Finished Product Examination of Retained Samples," states QA or a designee should inspect samples, but only leakage was checked for foil-packaged products, inhibiting direct inspection of vials.

Employee training in GMP procedures is inadequate. Warehouse personnel conducted the 11/12/2021 retain inspection without prior finished product inspection training, which occurred on 4/14/2022. Training was limited to "read and understand" for SOP-SC-QA-3251. The single employee performing the audit was not qualified to detect defects like discoloration or particulates.

Drug products are not stored under appropriate conditions. The warehouse temperature mapping study is inadequate, lacking scientific justification for monitor locations and heights, despite many products requiring storage between 2-25 degrees C (36-77 F). The warehouse manager stated current specifications are in degrees F, and the 2020 study and subsequent 3-year review did not establish worst-case monitoring locations.