Hoping Lonza s learnt their lessons from past FDA inspections.
https://www.fiercepharma.com/manufacturing/fda-blasts-lonza-facility-form-483-derailed-bristol-myers-plan-liso-cel-nod-by-2020
FDA blasts Lonza facility in Form 483 that derailed Bristol Myers' plan of liso-cel nod by 2020
'Lonza didn’t exactly have a clean slate when it comes cell therapy manufacturing. Back in 2017, the Swiss CDMO’s facility in Walkersville, Maryland, was hit with an FDA warning letter over issues including validation and aseptic process simulations.'
Ann: Third Quarter Results Presentation, page-13
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