FDA Warns Epilepsy Drug Maker Over API Labeling

According to a recent in-Pharma Technologist article, the FDA issued a warning letter to China’s Lumis Global Pharmaceuticals following an inspection of the company’s active pharmaceutical ingredient (API) plant in Wuhan Hubei. The letter states, “You omitted the name and address of the original API manufacturers on the certificates of analysis (COA) you issued to your customers, and did not include copies of the original batch certificate.”

Lumis also failed to record the date, time, and the employee who conducted relabeling for distributed API. The main API packaged at the facility is gabapentin, used to treat neuropathic pain and seizures.