# FDA 483 - Yuhan Chemical Inc. - January 12, 2024

Source: https://www.keypedia.com/records/483/yuhan-chemical-inc/1b57ea1b-2f41-44b0-ad24-b87b6179be24

> FDA 483 for Yuhan Chemical Inc. on January 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yuhan Chemical Inc.
- Inspection Date: 2024-01-12
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: An FDA inspection conducted at Yuhan Chemical, Inc. from January 8 to January 12, 2024, identified significant concerns regarding the firm's water sampling practices. The inspection, which focused on the company's role as an Active Pharmaceutical Ingredient (API) manufacturer, revealed inadequate assurance that water samples used for production accurately represent the quality of water in use. Specifically, the FDA investigator observed multiple deficiencies in the firm's approved water sampling procedures and associated documentation. For instance, although standard operating procedures require flushing the water system before sample collection, batch records lacked evidence that production personnel performed this critical step. Furthermore, the company failed to document the exact collection times for microbial enumeration test samples, making it impossible to verify that these samples were tested within the required timeframe. Lastly, documentation for water samples collected to represent worst-case conditions, specifically before system sanitation, only included the date and not the time relative to the sanitation process, hindering verification of proper sampling. These observations highlight critical areas where Yuhan Chemical, Inc. must implement corrective actions to ensure the reliability of its water quality monitoring, which is crucial for maintaining product quality and compliance with Good Manufacturing Practices.

## Related Documents

- [483 - 2024-01-12](https://www.keypedia.com/records/483/yuhan-chemical-inc/f9cec592-4f35-411e-a903-f0bc3a806e3b)

## Related Officers

- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)
- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/yuhan-chemical-inc/e849010a-40f7-445b-9bc8-de7e15900a80

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa