FDA 483 - BLV licht- und Vakuumtechnik GmbH - August 23, 2019

An FDA inspection of BLV licht- und Vakuumtechnik GmbH, a UV lamp manufacturer in Steinhoring, Bavaria, revealed six significant quality system deficiencies. The firm lacked adequate procedures for statistical techniques, process validation, in-process product acceptance, and control of nonconforming materials. Repeat observations highlighted ongoing issues with corrective and preventive actions and insufficient device history records.