FDA 483 - Similasan AG - April 04, 2023

Similasan AG, a homeopathic manufacturer, underwent an FDA inspection from March 27-31 and April 3-4, 2023. The inspection revealed several significant observations detailed in an FDA Form 483, indicating deviations from Good Manufacturing Practices (GMP) for drug products. Main violations included inadequate validation of sterilization processes, specifically concerning media fill batch sizes and the scientific justification for particle visual inspection frequency of sterile products. The firm also failed to thoroughly investigate unexplained discrepancies and out-of-specification results for sterile products, and its investigations into customer complaints for lack of effect or adverse events were insufficient, often omitting evaluation of retain samples. Furthermore, cleaning and maintenance procedures for manufacturing equipment were deficient, lacking detailed methods, equipment specifications, and proper cleaning validations. Finally, the quality control unit demonstrated inadequate oversight, releasing sterile products without properly reviewing test procedures for active ingredient content, maintaining records for standard preparation, or ensuring accurate finished product test results, including omitted positive control testing. Similasan AG is now required to implement comprehensive corrective and preventive actions to ensure its manufacturing, quality control, and validation processes fully comply with regulatory standards, thereby upholding product quality and patient safety.