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

Source: https://www.keypedia.com/records/483/second-tokushima-factory-otsuka-pharmaceutical-co-ltd/eb2c8860-5edc-4644-ae11-0320df185e13

> FDA 483 for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. on March 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Inspection Date: 2024-03-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

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- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/second-tokushima-factory-otsuka-pharmaceutical-co-ltd/d07820ec-a994-41cb-b667-509183a6cc4a

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c