FDA 483 - Kelix bio (Malta) Ltd. - December 16, 2022

Kelix bio (Malta) Ltd. received a Form 483 following an inspection that identified significant deficiencies in their drug manufacturing processes. Observations included a failure to thoroughly investigate batch discrepancies, inadequately designed equipment for sampling, and deficiencies in aseptic processing area cleaning. Additionally, the firm failed to document established test procedures at the time of performance.