The FDA issued a warning letter to a South Korean OTC manufacturer Dermameal for violations at its facility in Gyeonggi-do, including the incomplete quality testing and an inadequate stability program.
An agency inspection revealed that the facility failed to ensure that every drug product batch was released only after being fully tested for quality. Of the 41 lots the investigator reviewed, more than half were distributed before microbial testing was completed. The company justified its actions by saying its customer accepted the practice.
“Releasing drug products before completing all required testing is unacceptable and increases the risk that drug products that do not meet their quality attributes are distributed to consumers,” the agency said.