FDA 483 - Sartorius Stedim North America, Inc. - June 23, 2023

Sartorius Stedim North America, Inc. in Cambridge, MA, a Control Test Laboratory, received a Form 483 with two observations. The inspection revealed significant deficiencies in equipment qualification and maintenance for environmental monitoring systems, leading to data integrity and access issues. Additionally, the Quality Unit failed to ensure timely closure of numerous quality event investigations, indicating a breakdown in quality system procedures.