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# 7 Observations in Korea’s Hugel FDA-483
- URL: https://www.fdaweb.com/7-observations-in-koreas-hugel-fda-483/
- Published: 2022-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:58:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152678

FDA has released the form FDA-483 issued following an 8/12-8/20/21 inspection at the Hugel drug substance and drug product manufacturing facility in Chuncheon, Gangwon, Korea. The seven inspection observations were:

- *Clostridium botulinum* spore containment in the drug manufacturing areas is inadequate to mitigate spore cross-contamination risk in other manufacturing areas;
- decontamination of *Clostridium botulinum* spores and toxin in the drug substance manufacturing area is inadequate;
- environmental monitoring is insufficient to ensure that the drug product manufacturing areas are not contaminated with *Clostridium botulinum* spores as *Clostridium* spores are not monitored as part of environmental monitoring;
- investigation of out-of-specification DV19-019 for identification and purity by SDS-PAGE is inadequate;
- the standard operating procedure for logbook preparation and management was not updated promptly to include adequate controls to prevent the loss of logbooks;
- the working cell bank lot used to manufacture the drug substance lots and submitted in \[redacted\] is different from a working cell bank lot number used to manufacture a \[redacted\] drug substance during inspection; and
- a heavily redacted observation involving a drug product batch exceeding the specified filling time.