FDA warns Korean drugmaker for repeat violations

Oct. 19, 2018

The U.S. FDA issued South Korea-based Hanlim Pharm a warning letter over poor aseptic practices and inadequate processes for documentation, among other violations of good manufacturing practice (GMP).

Based on findings from a facility inspection in late January/early February of this year, the warning noted poor aseptic practices, inadequate design of aseptic lines, failure to monitoring environmental conditions in aseptic processing areas, as well as numerous data integrity and security issues.

Similar GMP violations had been observed during FDA visits to the Gyeonggi-do site in 2014 and 2016.

The FDA requested that Hanlim respond to the cited violations by providing a risk assessment on aseptic technique and cleanroom behavior, and an investigation into the extent of the inaccuracies seen in data records and reporting, among other corrective and preventive actions prior to consider lifting of the import alert the agency placed on the company in May.

Read the Warning Letter
Read the RAPS coverage