FDA 483 - Alfa Wassermann, Inc. - September 27, 2022

An FDA inspection of Alfa Wassermann, Inc. in West Caldwell, NJ, a manufacturer of clinical chemistry systems, revealed significant deficiencies in their quality system. Observations included inadequate device history records, insufficient procedures for manufacturing material control, and a lack of established processes for equipment calibration, complaint handling, statistical techniques, process controls, and employee training. These issues indicate a broad failure to ensure devices are manufactured and controlled in accordance with established quality system requirements.