- AngioDynamics (NASDAQ:ANGO) receives a Warning Letter from the FDA related to observations noted during on-site inspections of the firm's Navilyst Medical facilities located in Marlborough, MA and Glens Galls, NY this year.
- The deficiencies identified pertain to design control processes related to packaging validations and accelerated and real time aging testing in the company's fluid management and PICC families of products, inconsistency of a manufacturing product test process used among similar valved PICC products, a particular verification test of valved PICC products and non-conforming product control procedures.
- The company intends to rectify the deficiencies promptly.