FDA 483 - Evoqua Water Technologies LLC - May 14, 2024

An FDA inspection of Evoqua Water Technologies LLC in Buena Park, CA, revealed significant deficiencies in their quality system and medical device labeling and registration. The firm failed to conduct internal quality audits, and their carbon tanks for hemodialysis lacked unique device identifiers (UDI) on labels and were not registered in the Global Unique Device Identification Database (GUDID). Additionally, device history records were incomplete, lacking UDI information, primary identification labels, and raw material identification.