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Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.
In a press release on April 25, 2017, Lonza said its first-quarter earnings were strong, despite some issues with its bioscience solutions division. In the first-quarter earnings overview, the company said that while robust growth in its biotech and pharma segment was driven by strong demand in its mammalian manufacturing and clinical development/licensing areas, business in the bioscience sector was “softer” due to quality issues at its Walkersville, MD facility.
During the call, Lonza revealed it received a warning letter from FDA a day earlier on April 24, 2017 related to technical issues involving validation and aseptic process simulations at the Walkersville plant. In response, the company says it “takes this issue seriously, and has already started to address all issues raised by FDA.” The Walkersville site is largely a cell therapy manufacturing facility.
Lonza said it does not anticipate the issues with the Walkersville plant to have a major financial impact on the overall performance of its biotech and pharma segment.