FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Korean Manufacturer Slapped With Warning Letter Over GMPs

Oct. 25, 2018

The FDA hit South Korean drugmaker Hanlim Pharma with a warning letter for current GMP and other deficiencies observed during an inspection of its OTC manufacturing facility in Gyeonggi-do province earlier this year.

The agency flagged the firm’s poor aseptic practices during set-up and filling operations for one of its sterile solutions and said they created a significant risk of microbial contamination.

Specifically, as an operator prepared for filling operations, he touched the sterile solution between an ISO-5 and ISO-7 area. He continued to set up equipment in the ISO-5 aseptic filling zone without disinfecting his hands, possibly transferring microorganisms between the areas, the agency said.

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