Chinese OTC Drugmaker Draws Warning for Testing Failures
The FDA issued a warning letter to an over-the-counter drug manufacturer in Eastern China for multiple testing violations at its facility.
The company, Huaian Zongheng Bio-Tech in Jiangsu, released some OTC drug products without testing them for their labeled active ingredient, the agency said.
“Complete testing of each batch before release is essential to determine if the drug products you manufacture meet appropriate specifications,” the FDA said.
The company also failed to test components used in drug manufacturing to confirm their identity, neglecting to conduct at least one identity test for each lot of certain active ingredients.