# FDA 483 - Hisamitsu Pharmaceutical Co., Inc. - July 04, 2025

Source: https://www.keypedia.com/records/483/hisamitsu-pharmaceutical-co-inc/31cf3b6a-51aa-4666-9ba8-9e482a16e270

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

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## Details

- Record Type: 483
- Company Name: Hisamitsu Pharmaceutical Co., Inc.
- Inspection Date: 2025-07-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Hisamitsu Pharmaceutical Co., Inc. in Tosu, Saga, Japan, received a Form 483 from the FDA following an inspection from June 30 to July 4, 2025. The inspection revealed significant deficiencies in quality control, including inadequate investigations into unexplained discrepancies and a failure to establish and follow robust production and process control procedures. Additionally, the firm demonstrated insufficient laboratory controls for water system monitoring and microbial testing, indicating a lack of assurance regarding drug product quality and purity.

## Related Documents

- [483 - 2019-05-31](https://www.keypedia.com/records/483/hisamitsu-pharmaceutical-co-inc/7538a4f6-92de-411e-8105-38c145bacc97)

## Related Officers

- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/hisamitsu-pharmaceutical-co-inc/86a5b8bc-8a98-4ed8-a8b6-895f8012b1cb

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