The warning letter was sent on March 2 to Lumis following an inspection by the US Food and Drug Administration (FDA) at the firm’s active pharmaceutical ingredient (API) plant in Wuhan, Hubei last September.
The deviations from cGMP cited by the Agency included failures in the labelling of API made at the plant.
“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,” the FDA said.
“For multiple API, you generated COA by copying and pasting analytical results from the original API manufacturers, replacing the manufacturers’ information with your letterhead, then issuing these COA to your customers.”
The Agency also noted Lumis failed to record the time, date and the employee who conducted relabeling operations for distributed API.
Gabapentin
One of the APIs packages at the facility is gabapentin, used to treat seizures and neuropathic pain. The label for the ingredient stated: “Manufactured under cGMP conditions by: Lumis Global Pharmaceuticals Co., Ltd,” which the FDA said was misleading.
“It indicates that the manufacturer of the API is Lumis Global Pharmaceuticals Co., Ltd. instead of (b)(4). Therefore, the gabapentin APIs is misbranded under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that the API labeling is misleading.”
“The label of Lumis’ API product is misbranded under section 502(b)(1) because it misidentifies Lumis, which is a distributor or packer, as the manufacturer. As evidenced by the certificates of analysis, (b)(4) is the manufacturer of the gabapentin API, not Lumis Global Pharmaceuticals Co. Ltd.”
And a further violation was that Lumis shipped drugs from a manufacturer on FDA Import Alert 66-66 – “APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122.”
According to the FDA, Lumis “shipped (b)(4) USP API manufactured by this firm to the United States in February 2015 and declared that [it was] the manufacturer on importation documents.”