# FDA 483 - Chugai Pharmaceutical Co., Ltd. - August 30, 2019

Source: https://www.keypedia.com/records/483/chugai-pharmaceutical-co-ltd/e187fb7d-6a0a-451b-b1a8-e8f2159cfd4a

> FDA 483 for Chugai Pharmaceutical Co., Ltd. on August 30, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chugai Pharmaceutical Co., Ltd.
- Inspection Date: 2019-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Chugai Pharmaceutical Co., Ltd. in Fujieda, Japan was inspected from August 26-30, 2019, revealing significant deficiencies. The firm failed to thoroughly review unexplained discrepancies, leading to the release of drug batches with foreign matter and inadequate investigation into contamination sources. Additionally, the quality control unit did not ensure proper humidity storage conditions for empty capsules, potentially affecting their quality and purity.

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## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/chugai-pharmaceutical-co-ltd/5261bb2e-233a-40e3-8aa3-3e7b0b70dd29

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1