483
Boehringer Laboratories, Inc.Boehringer Laboratories, Inc. – FDA 483, Jun 24, 2026
Record Details
An FDA inspection of Boehringer Laboratories, Inc. in Phoenixville, PA, revealed significant deficiencies in the manufacturing and design controls for their new VISIGI® LUX medical device. The firm failed to adequately document process validation and maintain a complete design and development file, leading to issues like unverified design inputs and customer complaints. These observations indicate serious non-compliance with quality system regulations.
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ID · ab51cf7c-2456-48ee-a61c-2c1de4c806b7
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