FDA 483 - Similasan AG - April 04, 2023

Similasan AG, a homeopathic manufacturer in Jonen, Switzerland, was cited for significant deficiencies in its sterile drug product manufacturing processes. Observations included inadequate sterilization process validation, insufficient investigation of out-of-specification events and product complaints, and poorly defined cleaning procedures. Additionally, the quality control unit failed to properly review and approve test procedures and released products with inaccurate test results.