FDA 483 - Zile Bonbons Ag - July 12, 2023

An FDA inspection of Zile Bonbons Ag, an OTC drug manufacturer in Rupperswil, Switzerland, revealed significant deficiencies in their manufacturing processes. The firm failed to ensure drug product expiration dates were supported by adequate stability data and lacked thorough investigations into out-of-specification results. Additionally, issues were identified with laboratory controls, production procedures, batch records, equipment qualification, cleaning validation, component identification, and change control processes.