5 Observations on Hugel FDA-483

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.