FDA slaps warning letter on Chinese contractor making OTC children's drug

FDA has issued a warning letter to Foshan Jinxiong Technology, a contract manufacturer of OTC drugs for children. The Chinese drugmaker has been put on an import alert list since February, which prohibits its products from entering the United States.

FDA has issued a warning letter to Foshan Jinxiong Technology, a contract manufacturer of OTC drugs for children. The Chinese drugmaker has been put on an import alert list since February, which prohibits its products from entering the United States. During an inspection last August, inspectors found that instead of testing each lot for identity and strength of the active ingredient prior to distribution, the company was asking clients to do the test after product release, and it did not have those pieces of information on retained samples to assess the quality of already-distributed drugs. FDA also found that Jinxiong failed to test incoming components sold to them, and it relied only on certificates of analysis from unqualified sources. FDA is asking the drugmaker to provide test results on retained samples of all drugs that have already been sent to the United States and to conduct all chemical and microbial tests before product disposition. Additionally, the firm is required to perform tests for incoming components and to determine whether components or final products have been assigned appropriate expiration dates.