The US Food and Drug Administration (FDA) posted a Warning Letter to Lonza for its site in Walkersville, Maryland, based on its inspection of the facility from January 18, 2017 through February 6, 2017. The findings were based on various quality issues relating to validation and aseptic process simulations. 

The Walkersville facility is clinical cell processing facility and supports the company’s biosciences business. Lonza acknowledged receipt of the Warning Letter, dated April 24, 2017, in its first-quarter earning release. “Lonza takes this issue seriously,and has already started to address all issues raised by the FDA,” said the company in its release. The company said it expects minimal financial impact on its overall 2017 Pharma & Biotech segment performance.

Source: US Food and Drug Administration and Lonza