The FDA hit a South Korean drug manufacturer for serious violations at its Chuncheon, Gangwon facility, including lax investigations and testing deficiencies.
An inspection of the FMG facility revealed an inadequate CAPA following a report of incorrect packaging that led to a product mix-up. The quality unit failed to document its review of packaging records to determine the cause of the mix-up and the CAPA had no conclusions or follow-up.
The FDA investigators also noted multiple tasks the quality control unit failed to conduct. For example, it didn’t validate an inventory management system implemented in June 2019 or put the system into operation using an approved change control process.