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# 5 Observations on Hugel FDA-483
- URL: https://www.fdaweb.com/5-observations-on-hugel-fda-483/
- Published: 2024-09-24T12:00:00.000Z
- Updated: 2026-09-14T14:42:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157846

FDA has just released the form FDA-483 issued following a 2/27-3/16/2023 inspection at the Hugel drug substance and product manufacturing facility in Gangwon-do, Republic of Korea. The five specific inspection observations were:

- failure to have an established cleaning and disinfection program to prevent the introduction of microbial contamination into the controlled manufacturing environment in drug substance and drug product manufacturing facilities;
- laboratory records are deficient in that the firm has not established adequate procedural controls to ensure assay data traceability, reliability, and accuracy;
- failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- the environmental monitoring program for the drug substance manufacturing facility is deficient; and
- the company quality control unit’s oversight of the good manufacturing practices manufacturing operations is inadequate.