FDA 483 - USHIO GERMANY GmbH - August 23, 2019

During an FDA inspection conducted from August 19-23, 2019, BLV Licht- und Vakuumtechnik GmbH, a UV lamp manufacturer located in Steinhoring, Germany, was cited for multiple quality system deficiencies. The inspection identified six observations regarding the firm's adherence to regulatory expectations.

Key violations included inadequate procedures for identifying valid statistical techniques to establish and control process capability and product characteristics, particularly concerning in-process testing and sampling. Several critical manufacturing processes, along with their associated software (e.g., involving machines 2281, 2282, 2183, and 449), were found to be inadequately validated, a repeat observation from a previous inspection. Additionally, procedures for accepting in-process products lacked sufficient acceptance criteria and guidance for handling non-conforming items.

The company's control of nonconforming materials was also found to be deficient, with procedures lacking the necessary detail for consistent application. Furthermore, the corrective and preventive action (CAPA) system was inadequate, another repeat observation, as procedures failed to require thorough investigations into nonconformity causes or verification of corrective action effectiveness. Finally, device history records did not consistently include primary identification labeling or unique device identifiers, indicating a failure to demonstrate manufacturing in accordance with device master records. BLV Licht- und Vakuumtechnik GmbH committed to implementing corrective actions for these observations by December 2019 or March 2020.