# FDA 483 - Hugel Inc. - February 01, 2024

Source: https://www.keypedia.com/records/483/hugel-inc/6b694a3e-ecef-44c5-a2d4-8713fa0d0ef2

> FDA 483 for Hugel Inc. on February 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hugel Inc.
- Inspection Date: 2024-02-01
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hugel, Inc., a drug substance and drug product manufacturer in Chuncheon, Korea, received two observations during an FDA inspection. The firm was cited for not establishing and following procedures to prevent microbiological contamination of sterile drug products, specifically concerning media fills. Additionally, visual inspection procedures were found to be inadequate, particularly regarding ambient lighting.

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## Related Officers

- [Joao Pedras-Vasconcelos](https://www.keypedia.com/people/joao-pedras-vasconcelos/143cf25e-168d-43da-adc8-9107c4f01b44)
- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

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