FDA 483 - ABV Electronics, Inc DBA Sienna Corporation - August 15, 2024

ABV Electronics, Inc DBA Sienna Corporation, a contract manufacturer in Suwanee, GA, was cited for multiple quality system deficiencies during an FDA inspection. The observations include inadequate documentation and approval of process validation, lack of written Medical Device Reporting procedures, insufficient complaint handling procedures, and deficiencies in personnel training. These issues indicate a need for significant improvements in the firm's quality management system.