Loading…
Woorilife & Health, a South Korean manufacturer of over-the-counter drug products including toothpaste, failed to conduct required identity testing on incoming components at high risk of contamination with diethylene glycol (DEG) or ethylene glycol (EG), specifically glycerin, propylene glycol, and sorbitol solution, in violation of 21 CFR 211.84(d)(1). The facility's manufacturing methods, facilities, and controls did not conform to Current Good Manufacturing Practice (CGMP) regulations, resulting in the company's drug products being deemed adulterated under the Federal Food, Drug, and Cosmetic Act. The violations were identified following FDA's review of records submitted in response to two separate inspection requests in February and July 2023.