FDA warns China's Lumis over misbranded APIs
Chinese firm Lumis Global Pharmaceuticals became the latest to face the FDA’s ire as it was hit by a warning over its active pharmaceutical ingredient (API) facility in Hubei, China.
The company is accused of breaching current good manufacturing practice (cGMP) in the documenting and labelling of APIs at the plant. The FDA noted a number of transgressions; according to its report, Lumis had intentionally omitted mention of the name and address of the original API manufacturer on certificates of analysis given to customers, and resorted to copying and pasting erroneous information for multiple certificates. The company also failed to adequately document these recordings.
The FDA also took issue with labelling of Lumis’ seizure and neuropathic pain drug gabapentin, claiming that it misbranded the medication with the text “manufactured under cGMP conditions by: Lumis Global Pharmaceuticals”, rather than the original manufacturer. This breaches section 502(a) of the Federal Food, Drug, and Cosmetic Act, where the labelling of an API is misleading for asserting that Lumis themselves are the manufacturer, rather than distributor or packer.
Lumis is just the most recent company to find themselves on the receiving end of FDA warnings. In November last year, another Chinese firm – API manufacturer Beijing Taiyang Pharmaceutical Industry Company – was found attempting to intentionally impede FDA investigation by denying the organisation entry to certain parts of the facility, as well as wilfully misleading them. More recently in India, Hetero Labs employees were found shredding controlled documents at 1am, and an investigation of an oncology formulation plant owned by pharma giant Dr Reddy’s resulted in 13 separate observations from the FDA, sending shares to a three year low.