FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

South Korean OTC Drugmaker Cited for Cleaning, Data Issues

Aug. 22, 2019

The FDA found “moldlike” growth and other contaminants at Kumho Dental Pharmaceutical’s over-the-counter dental drug facility in Seoul, South Korea.

The FDA investigator saw the moldlike growth, dirt and dust throughout the facility and noted the firm had no environmental monitoring plan. The OTC dental products did not include recognized preservatives to help keep microorganisms from growing in them, according to the Form 483.

Alarmingly, the facility used no disinfectants or sanitizers to clean equipment and utensils used in drug manufacturing, and worn brushes were seen near an equipment wash area covered in moldlike growth.

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