FDA 483 - USHIO GERMANY GmbH - August 23, 2019

An FDA inspection of BLV licht- und Vakuumtechnik GmbH, a UV Lamp manufacturer in Steinhoring, Bavaria, Germany, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for statistical techniques, process validation, in-process product acceptance, nonconforming product control, and corrective and preventive actions. Several observations, including issues with process validation and CAPA, were repeats from a previous inspection, indicating persistent quality control problems.