FDA 483 - Janssen Vaccines Corporation - March 02, 2022

Janssen Vaccines Corp. in Yeonsu-gu, Incheon, Republic of Korea, was inspected from March 2-10, 2022, and received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, equipment validation and qualification, and laboratory controls. These issues indicate a high risk of microbiological contamination and product quality issues for sterile drug products.