483
Merck Serono S.p.A.FDA 483 - Merck Serono S.p.A. - May 10, 2023
Discuss this record with AI
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.
Record Details
An FDA inspection of Merck Serono S.p.A. - (MS-Bari), a drug product manufacturer in Bari, Italy, revealed multiple deficiencies in their manufacturing operations. Observations included issues with aseptic processing design, inadequate control strategies for product and excipients, and unvalidated sterilization processes. Further concerns were raised regarding inadequate equipment maintenance and insufficient cleaning and disinfection practices in aseptic areas.
Open in Dashboard
ID · a8eb71fd-5dd2-498d-9056-6668c859061a