FDA 483 - Shiseido America Inc. - November 01, 2018

During an FDA inspection conducted from October 22 to November 1, 2018, Shiseido America Inc., located in East Windsor, NJ, received a Form FDA 483 detailing significant observations. The inspection revealed three primary areas requiring attention under the regulatory framework of Good Manufacturing Practices (GMP).

Firstly, the company's laboratory control system exhibited inadequate specifications for active ingredients in its Over-the-Counter (OTC) drug products. Notably, the "Shiseido Ultimate Sun Protection Cream Broad Spectrum SPF 50+" and 62 other products were found to have Octinoxate levels that exceeded established monograph limits, compromising product identity, strength, quality, and purity.

Secondly, the quality system lacked sufficient procedures for investigating drug product failures. There were no written procedures for manufacturing investigations into out-of-specification results, and existing investigation protocols were not consistently followed, partly due to untrained personnel. This led to uninvestigated product failures, including issues with Octinoxate content and product hardness.

Lastly, deficiencies were noted in the facility and equipment system regarding preventative maintenance. Several critical manufacturing machines, such as homogenizers, mills, and mixer tanks, had overdue maintenance, raising concerns about potential malfunctions affecting product safety and quality.

Shiseido America Inc. is required to address these observations comprehensively to ensure full compliance with regulatory standards for drug product manufacturing.