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FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd., dated March 2, 2017, in response to an agency inspection of the company’s Wuhan, Hubei, China facility from Sept. 26–28, 2016. Inspectors found a variety of current good manufacturing practice (CGMP) violations concerning the misbranding, repackaging, and relabeling of APIs.
The warning letter states the company sent certificates of analysis (COA) to customers that contained analytical results that had been copied from the original API manufacturer. Lumis Global Pharmaceuticals, according to FDA, replaced the original API manufacturer’s information on COAs with Lumis Global Pharmaceuticals letterhead and omitted the original manufacturers’ name, address, and the name of laboratories that performed testing. “Customers and regulators rely on COA for information about the quality and sourcing of drugs and their components. Omitting information from COA compromises supply-chain accountability and traceability, and may put consumers at risk,” FDA stated in the letter.
Investigators also found the company had failed to hold API under appropriate CGMP controls and the quality unit had failed to ensure that API relabeling operations were CGMP compliant. API was also found to be labeled as being manufactured under CGMP conditions by Lumis Global Pharmaceuticals Co., Ltd. when the API was actually manufactured by another company, which FDA considers to be misbranded under the Federal Food, Drug, and Cosmetic Act.
The warning letter also states that the company shipped API to the United States in February 2015 that was manufactured by a company that had been on Import Alert 66-66. The importation documents for the shipped API, however, had Lumis Global Pharmaceuticals Co. Ltd. listed as the manufacturer.
FDA requested the company provide the agency with written procedures for transferring quality and regulatory information and provide “a plan to establish, document, and implement an effective system for managing quality. Include written procedures for CGMP-related activities and the roles of personnel responsible for oversight.” The agency also stated in the letter that the company had been placed on Import Alert 66-40 on Feb. 15, 2017.