The FDA warned a Korean manufacturer over significant GMP violations observed during an inspection in March, including its failure to test incoming components.
The company, Dae Young Foods, was also cited for inappropriate labeling of components, and for having an inadequate quality control unit.
The FDA determined that one of the company’s gum products, Smoker’s Appetite Relief, was a misbranded drug because the labeling included claims that it temporarily relieved excessive appetite, food cravings, overeating, and irritability.
The investigator also found that numerous ingredients in the product were not declared on the finished product label.
The firm also neglected to test all incoming drug components for quality and identity before their use, and failed to confirm the reliability of certain suppliers’ certificates of analysis.
In addition, the facility lacked records of annual product reviews, approval or rejection of drug products, change control and batch record reviews, the agency said.