FDA 483 - Northwind Pharmaceuticals LLC - September 26, 2025

Northwind Pharmaceuticals LLC, a repacker and distributor in Indianapolis, IN, was cited for significant deficiencies in its quality control unit during an FDA inspection. The firm failed to adequately follow established procedures, leading to issues with cleaning verification, documentation of packaging activities, temperature monitoring, and product quarantine. These findings indicate a lack of adherence to quality control responsibilities and procedures.