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

Source: https://www.keypedia.com/records/483/hugel-inc/727c4a4e-fb4b-478b-a667-f03ab3670285

> FDA 483 for Hugel Inc. on August 20, 2021. Product: Food. 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: Food
- Office Name: Division of Biotechnology Manufacturing
- Summary: An FDA inspection of Hugel, Inc., a drug substance and drug product manufacturer in Chuncheon, Gangwon, Korea, was conducted from August 12-20, 2021. The inspection identified several deficiencies.

Observations included inadequate containment of *Clostridium botulinum* spores in drug substance manufacturing areas, posing a cross-contamination risk to drug product areas, with no procedure to prevent personnel movement between these areas. Decontamination of *Clostridium botulinum* spores and toxin was also found to be inadequate, with a spectrometer at risk of contamination and disinfectant qualification studies failing to demonstrate effectiveness against spores and toxin. Environmental monitoring was insufficient as *Clostridium botulinum* spores were not monitored in drug product manufacturing.

Furthermore, an investigation into an out-of-specification (OOS) result for identification and purity (DV19-019) was deemed inadequate, as re-testing was not conducted to confirm the presumed root cause. The SOP for logbook management (AWLS-QA-015:FOS) was not updated promptly after twelve incubator logbooks went missing in 2016 and 2017. A different working cell bank (WCB) lot was used for drug substance manufacturing during the inspection compared to what was submitted, and comparability data were lacking. Finally, a drug product batch failed due to exceeding validated manufacturing time, attributed to delays, damaged vials, and operator breaks (DV2

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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-biotechnology-manufacturing/3e3018f1-aa48-4010-a554-96f557f17c55