FDA 483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. - March 22, 2024

This FDA Form 483 document details observations from an inspection, identifying several deficiencies in the facility's operations and quality systems.

**Observation 1** notes that equipment and utensils, specifically non-dedicated Equipment ID# 5G2-EQ12, are not adequately cleaned and maintained. On March 18, 2024, residue was found on the product after the filter following a production campaign. A swab sample revealed unknown peaks and the presence of a drug substance manufactured between March 5 and March 8, 2024, indicating cross-contamination.

**Observation 2** highlights deficiencies in the system for monitoring environmental conditions within aseptic processing areas.

**Observation 3** indicates that deviations from written sampling plans are not justified. The document "Specification for Environment Control" (SHC-17, effective September 26, 2023) specifies "rfc~ locations" for contact plate bacteria sampling, but on March 20, 2024, the firm conducted sampling at "CbTC1" of "Cb><4j" pre-determined locations.

**Observation 4** addresses the acceptance of component supplier analysis reports without performing at least one specific identity test on each component. * **a)** The firm routinely purchases a product contact raw material for sterile grade API production but failed to perform identity tests on at least lots received since March 1, 202