# FDA 483 - Yuhan Chemical, Inc. - September 22, 2017

Source: https://www.keypedia.com/records/483/yuhan-chemical-inc/4c55319a-b4a5-405c-8351-42bab0c51344

> FDA 483 for Yuhan Chemical, Inc. on September 22, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yuhan Chemical, Inc.
- Inspection Date: 2017-09-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Yuhan Chemicals Inc., an API manufacturer in Ansan-si, Gyeonggi-do, South Korea, revealed critical deficiencies in quality control and production. These issues included a failure to adequately investigate a customer complaint involving blood-contaminated API, the use of out-of-trend intermediate materials without proper justification, and insufficient controls over computerized systems and equipment cleaning. The findings indicate a lack of robust quality management practices that could compromise the safety and quality of APIs destined for the U.S. market.

## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.keypedia.com/companies/yuhan-chemical-inc/ab32ef04-730e-4d05-a241-f163d065a70d

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd