FDA 483 - Taenaka Kogyo Co., Ltd. - April 12, 2024

The FDA Form 483 inspection identified four observations at the facility manufacturing drug substances.

**Observation 1** notes inadequate training and assessment of employees. Specifically, operators performing 100% visual examination of finished drug substances lack assessment to ensure their capability in detecting contaminants. This impacts drug substance lots manufactured, released, and distributed since early 2022.

**Observation 2** addresses ventilation systems, stating that production suites are not adequately designed and constructed to minimize contamination risks from the outside environment during drug substance manufacturing.

**Observation 3** concerns the monitoring of controlled temperature storage chambers. The alarm systems for these chambers, which store GMP drug substance manufacturing materials, send email notifications for temperature excursions to specific personnel (QC Manager, QC Test Manager, Analytical Equipment Manager). However, the firm lacks procedures to ensure these personnel monitor emails outside of standard office hours (8:00 am - 5:00 pm, Monday - Friday), potentially delaying the addressing of temperature excursions.

**Observation 4** highlights issues with microbiological purity testing. Growth media plates used for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) testing of drug substance lots are not adequately tested for growth promotion. For example, in 2023, only one manufacturer's lot of growth media plates was tested, despite multiple lots being received. These tests are critical for the release of drug substance lots, of which numerous have been released