# FDA 483 - Takeda Pharmaceutical Company Limited - November 26, 2019

Source: https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/dc0ab72d-608b-4770-b885-4d26b8d7b7cf

> FDA 483 for Takeda Pharmaceutical Company Limited on November 26, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2019-11-26
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 details seven observations from an inspection, highlighting significant deficiencies in the facility's quality control, aseptic processing, and equipment maintenance.

**Observation 1** notes the Quality Unit's failure to adequately oversee production, aseptic controls, and equipment maintenance. It also cites unauthorized and undocumented full-size trial runs on filling lines, lacking proper reconciliation, line clearance, and destruction procedures.

**Observation 2** indicates that investigations into batch failures, specifically involving black metal particles, were not extended to other potentially affected batches.

**Observation 3** identifies inadequate validation of aseptic and sterilization processes. This includes the absence of aseptic process simulations (media fills) after HVAC re-qualification and system maintenance, contrary to SOP H-SOP-PRD-0010. Furthermore, the design of the aseptic process simulation for the sterile line did not represent actual production operations, and a failed sterility test was attributed to operator error without requiring operators to conduct media fills of this specific process.

**Observation 4** points to inadequate controls for in-house sterilization and replacement of gowns for classified areas, with observed discrepancies in sterilization dates and lack of access control.

**Observation 5** reveals that two batches of drug product (lots [redacted]) that failed sterility testing were released based on re-test passing results, despite an investigation lacking evidence to support the invalidated initial tests.

**Observation 6** details issues with equipment maintenance, specifically an equipment

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## Related Officers

- [Steven M. Weinman](https://www.keypedia.com/people/steven-m-weinman/66ffc074-e34a-4b53-a525-0d4a25c6a220)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

Company: https://www.keypedia.com/companies/takeda-pharmaceutical-company-limited/0f6bd1ca-94a2-41f0-a8dd-1af20069e6cf

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