FDA 483 - Ophtapharm AG - December 12, 2017

An FDA inspection conducted at a finished drug product manufacturing facility in Hettlingen, Zurich, Switzerland, from December 4 to December 12, 2017, resulted in a Form 483 detailing significant observations. While the firm name is not provided, the inspection highlighted several areas of non-compliance with regulatory expectations for pharmaceutical manufacturing. Key issues included the failure to adequately establish and document the accuracy, sensitivity, and reproducibility of analytical test methods. Specifically, method transfers were incomplete, lacking essential forced degradation studies to ensure specificity for stability-indicating procedures used in product release. Additionally, the inspection identified deficiencies in maintaining separate and defined areas to prevent contamination during aseptic processing, evidenced by an uninvestigated smoke study failure in a critical aseptic filling room. Procedures for cleaning and equipment maintenance were also found to be deficient, lacking detailed instructions and efficacy evaluations for sanitization in difficult-to-reach areas. Lastly, the firm did not consistently follow its written stability testing program, omitting required examinations for product stability studies. The company is expected to implement prompt corrective actions to address these observations and ensure compliance.