FDA 483 - Sato Pharmaceutical Co., Ltd. - July 03, 2018

An FDA inspection conducted from June 25 to July 3, 2018, at Sato Pharmaceutical Company Limited in Hachioji, Tokyo, Japan, identified several deficiencies related to their drug manufacturing operations. The observations, documented in an FDA Form 483, indicate potential deviations from Current Good Manufacturing Practices.

Key issues included inadequate adherence to established quality control unit procedures. Specifically, standard operating procedures for microbiological testing data sheets were insufficient, and a discrepancy was noted where microbiological growth was observed but recorded as zero. Additionally, critical “dummy” samples used for foreign particle detection were utilized without proper procedural controls.

The inspection also revealed significant shortcomings in aseptic processing environmental monitoring. The company lacked a thorough risk assessment for air sampling points in the ISO 5 filling zone, did not have sufficient data to support decontamination frequencies, and failed to validate environmental swab methods and disinfectant efficacy studies. Furthermore, laboratory controls were deficient, as container closure integrity studies for sterile drug products had not been completed. Lastly, critical chromatographic data from standalone electronic instruments, essential for laboratory analysis, lacked proper backup procedures.

Sato Pharmaceutical is required to address these observations with detailed corrective and preventive actions to ensure compliance with regulatory standards.