FDA 483 - MediWound Ltd - November 15, 2022

MediWound Limited, a drug substance and drug product manufacturer in Yavne, Israel, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate aseptic processing controls, including environmental and personnel monitoring, microbial cross-contamination prevention, and cleaning/sanitization programs. Additionally, the firm's quality oversight, risk assessment for microbial contamination, and qualification of temperature-controlled storage areas were found to be deficient.