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Home » Alfa Wassermann Slapped with Form 483 for Inadequate Documentation and Procedures
Alfa Wassermann Slapped with Form 483 for Inadequate Documentation and Procedures
Alfa Wassermann, a West Caldwell, N.J.-based provider of chemistry analyzers, was handed a Form 483 for device history record (DHR) issues, lack of proper procedures for use and removal of manufacturing materials, and other lapses following a September 2022 inspection by the FDA.