FDA hits Hong Kong OTC drugmaker with warning letter

The FDA issued a warning letter to Hong Kong-based over-the-counter drugmaker Luen Wah Medicine, citing the company for not testing the identity and strength of each active ingredient in its products. The regulatory agency also cited Luen Wah for releasing products to the U.S. market “without testing for total aerobic microbial count and objectionable micro-organisms.” The letter, which was posted on the FDA’s website, followed a September 2017 inspection during which it was found that the company failed to ensure “that its drug products bore an expiration date that was supported by appropriate stability testing.”