# FDA 483 - Hugel Inc. - August 20, 2021

Source: https://www.keypedia.com/records/483/hugel-inc/21fcd217-7913-4979-9020-de9e0f5af888

> FDA 483 for Hugel Inc. on August 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hugel Inc.
- Inspection Date: 2021-08-20
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hugel, Inc. in Chuncheon, Gangwon, Korea, was inspected for drug substance and drug product manufacturing. The inspection revealed significant issues related to Clostridium botulinum spore control, including inadequate containment, decontamination, and environmental monitoring. Additionally, the firm had deficiencies in OOS investigations, logbook management, cell bank comparability, and batch filling time controls.

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## Related Officers

- [Mekonnen Lemma Dechassa](https://www.keypedia.com/people/mekonnen-lemma-dechassa/a210168b-86f6-4e9b-9f66-c1244abff0f9)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

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