FDA 483 - Meiji Seika Pharma Co., Ltd. - April 08, 2022

During an inspection conducted from April 4-8, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Meiji Seika Pharma Co., Ltd. The inspection revealed significant deviations from current Good Manufacturing Practices (cGMP), primarily concerning laboratory and quality control systems.

Key observations highlighted critical data integrity deficiencies in the laboratory. The FDA noted that input and output data were not adequately checked for accuracy, with numerous instances of analytical sequences being deleted without proper documentation or assessment of their impact on raw data. Furthermore, audit trails showed unexplained data run cancellations, and Standard Operating Procedures lacked clear guidelines for data alteration. Analysts were found to have excessive access privileges, allowing them to delete or modify data without adequate controls. Additionally, certain laboratory equipment, such as the dissolution apparatus, lacked continuous temperature monitoring and proper calibration for critical parameters.

The inspection also identified issues within the Quality System, including incorrect units in executed batch records leading to out-of-specification data, and failures to conduct and document risk assessments for change controls as per internal procedures. Unexplained discrepancies were not thoroughly reviewed, with examples like uninvestigated sample discoloration related to Out-of-Specification (OOS) results, and delays in notifying Quality Assurance for OOS events, coupled with data reprocessing without justification.

Meiji Seika Pharma Co., Ltd. is required to investigate these observations, implement comprehensive corrective and preventive actions, and provide a timely response to the FDA addressing these compliance issues to ensure product quality and integrity.