Lumis Receives FDA Warning Letter for China Manufacturing FacilityBy
Lumis Global Pharmaceuticals, a Wuhan, China-based manufacturer of active pharmaceutical ingredients (APIs), has received a Warning Letter from the US Food and Drug Administration (FDA) for cGMP violations at the company’s drug manufacturing facility in Wuhan. The FDA noted the violations during an inspection of the plant in September 26-28, 2016, which also included a misbranding of the the active pharmaceutical ingredient (API), gabapentin. The FDA reviewed Lumis’ November 9, 2016, response and noted that it addressed some of the agency’s observations, but did not address other issues that had been noted.
During its inspection, the FDA observed the following: omission of the identity of original API manufacturers on Lumis’ certificates of analysis issued to customers; failure to control API repackaging, relabeling, and holding operations wherein the company held unlabeled material in its “released for shipping” area; and poorly documented relabeling operations, which included failure to document time and date of relabeling operations for APIs distributed, the employee who conducted relabeling operations, and the signing and dating of records at the time relabeling activities were performed.
In addition, the FDA observed the misbranding of the gabapentin API, wherein labels for this API bore the statement “Manufactured under cGMP conditions by: Lumis Global Pharmaceuticals Co., Ltd.”, which the agency noted is misleading because Lumis is not the original manufacturer of this API.
In response to the Warning Letter, the FDA requires Lumis to provide written procedures for transferring quality and regulatory information, including the information sent to customers, and a plan to establish, document, and implement an effective system for managing quality, including written procedures for cGMP-related activities and the roles of personnel responsible for oversight.
Source: Food and Drug Administration