FDA 483 - Takeda Pharmaceutical Company Limited - September 14, 2010

An FDA inspection of Takeda Pharmaceutical Company Limited in Osaka, Japan, identified critical deficiencies in procedures for preventing microbiological contamination of sterile drug products. These issues included the use of uncalibrated equipment during annual qualifications and an employee failing to sanitize hands before performing aseptic manufacturing tasks. Additionally, the firm's aseptic processing areas were found to have an inadequate system for monitoring environmental conditions, particularly concerning personnel and pass box monitoring.