483
BLV licht- und Vakuumtechnik GmbHBLV licht- und Vakuumtechnik GmbH – FDA 483, Aug 23, 2019
Record Details
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.
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ID · ca99a354-e456-4381-88ca-80c23a2130de
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