# FDA 483 - Chugai Pharmaceutical Co., Ltd. - July 04, 2025

Source: https://www.keypedia.com/records/483/chugai-pharmaceutical-co-ltd/21a8b1f2-f960-4ae6-bb3e-6836197882ff

> FDA 483 for Chugai Pharmaceutical Co., Ltd. on July 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chugai Pharmaceutical Co., Ltd.
- Inspection Date: 2025-07-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Chugai Pharma Manufacturing Co., Ltd. in Fujieda-City, Shizuoka, Japan, revealed two significant observations. The firm failed to thoroughly investigate unexplained discrepancies, specifically regarding metal contaminants in batches after changing investigation thresholds. Additionally, established microbial testing procedures were not followed, as air bubbles were observed in test plates during bioburden analysis.

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## Related Officers

- [investigator](https://www.keypedia.com/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8