# FDA 483 - Hugel Inc. - March 10, 2023

Source: https://www.keypedia.com/records/483/hugel-inc/244a9899-9c37-4cf3-94cd-197b4717200f

> FDA 483 for Hugel Inc. on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hugel Inc.
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hugel, Inc. (Site 2) in Chuncheon-si, Republic of Korea, was inspected for its drug substance and drug product manufacturing facilities. The inspection revealed significant deficiencies across multiple areas, including inadequate cleaning and disinfection programs, compromised laboratory data integrity, and critical failures in aseptic processing and environmental monitoring. The firm's quality unit oversight was also found to be insufficient, indicating a broad lack of control over GMP operations.

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- [483 - 2023-03-10](https://www.keypedia.com/records/483/hugel-inc/91aac001-2d80-4687-a620-be062477583c)
- [483 - 2024-02-01](https://www.keypedia.com/records/483/hugel-inc/6b694a3e-ecef-44c5-a2d4-8713fa0d0ef2)

## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Yetao Jin](https://www.keypedia.com/people/yetao-jin/678b1dc3-37b8-4744-ad5c-6e403604dfd2)

Company: https://www.keypedia.com/companies/hugel-inc/c3f52dc8-7334-454e-b30b-24a21c659c7d

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