483
Kelix bio (Malta) Ltd.Kelix bio (Malta) Ltd. – FDA 483, Dec 16, 2022
Record Details
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.
View Company Profile
ID · 865dcc08-1f39-489b-95f0-66be1feb9d04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.