FDA 483 - Shiono Finesse Ltd. - June 08, 2018

During an FDA inspection conducted from June 4-8, 2018, at Shiono Finesse, Ltd., an Active Pharmaceutical Ingredient (API) manufacturer, several significant Current Good Manufacturing Practice (cGMP) deviations were observed. The inspection revealed eight observations requiring the company's attention. Key issues included a repeated observation regarding deficient electronic data review, where only PDF files were examined instead of raw electronic data. Inadequate equipment cleaning practices were noted, with residues found in equipment labeled as 'cleaned,' posing a risk of cross-contamination. The facility also lacked a comprehensive preventive maintenance program, focusing only on limited checks. Process validation was found to be insufficient, particularly concerning the absence of hold time studies under actual production conditions. Further observations highlighted deficiencies in raw material sampling procedures, the failure to conduct stability studies for API lots manufactured with new raw material suppliers after process changes, and inadequate supplier qualification processes, including reduced testing without sufficient justification. Finally, the firm lacked a program for visually inspecting reserve samples for deterioration. Shiono Finesse, Ltd. is required to address these observations with detailed corrective and preventive actions to ensure compliance with cGMP regulations and maintain product quality and safety.