The U.S. FDA has issued a warning letter to Foshan Jinxiong Technology, a contract manufacturer of over-the-counter drugs for children, citing four violations related to quality control.
The warning letter to the Chinese drugmaker’s facility in the city of Foshan came after an inspection last August. The firm has been put on an import alert list since February, banning all of its products from entering the U.S.
During the check, 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 didn’t have those pieces of information on retained samples to assess the quality of already-distributed drugs.
The FDA also criticized Jinxiong for lacking basic information identifying drug components, production equipment and lot numbers related to the manufacturing and control of each lot.
As it turned out, it wasn’t just the firm’s handling of the final products that appeared problematic. The agency also found that Jinxiong failed to test incoming components sold to them, instead relying only on certificates of analysis from unqualified sources.
What’s more, the firm didn’t have adequate written protocol to test the stability of drugs, nor did it have such data to support storage conditions and expiration dates. Though the company said in its response that it would test the stability of finished drugs up to three years, the agency found it inadequate because the firm’s own procedure doesn’t include chemical tests.
In providing suggestions for improvement, the FDA is asking the drugmaker to provide test results on retain samples of all drugs that have already been dispatched to the U.S., and to conduct all chemical and microbial tests prior to product disposition. Moreover, the firm is required to perform tests for incoming components and to determine whether components or final products have been assigned appropriate expiration dates, among others.
Before it meets the FDA’s requirement, Jinxiong could stay on import alert, while the FDA could reject drug applications that use it as a manufacturer.