US FDA warned OTC drug manufacturers from China and Hong Kong


The US Food and Drug Administration (FDA) released warning letters sent to two over-the-counter (OTC) drugmakers in China and Hong Kong.

In a warning letter to Taizhou, China-based over-the-counter (OTC) drugmaker Zhejiang Ludao Technology Co., Ltd., FDA cites the company for data integrity and product testing issues. FDA said it also found computer files in the recycle bin for the company’s stand-alone high-performance liquid chromatography (HPLC) system. According to FDA, the system did not have audit trail capabilities and the company could not explain why the files were deleted.

Prior to the inspection, FDA detained and tested samples from a batch of an OTC spray made by Zhejiang Ludao that had nearly twice the amount of active ingredient specified on the label. According to the agency, the company has agreed to reformulate the spray and update its test methods.

In a warning letter to Hong Kong-based OTC drugmaker Nan San Pharmaceutical Factory Limited, FDA says the company failed to conduct adequate laboratory testing and marketed misbranded products. The warning letter comes after FDA inspected the company’s facility in Kwun Tong Kowloon, Hong Kong in late September. As a result of the inspection findings, FDA placed the firm on import alert in January. According to FDA, Nan San failed to perform microbial limit tests for each batch of one of its products from 2013 to 2016.

FDA says the company set expiration dates for some of its products without adequately assessing the products’ stability characteristics. FDA also says that two of the company’s OTC products, Musflex and Easy-Flex, are misbranded as their labels do not declare their active or inactive ingredients.