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.”
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Luen Wah produces OTC drugs and devices for companies like Japan’s Takeda, Otsuka and Nichiban, and Germany’s Denk Pharma, according to its website.
As a result of the inspection, the FDA placed Luen Wah on its Import Alert list in January and recommended that the company hire a consultant to help it meet CGMP standards.
The agency has recently cited three OTC drugmakers for manufacturing issues, including Luen Wah, and earlier this month posted a voluntary recall by MarcasUSA and Industria Farmacéutica Andromaco for four lots of Pasta De Lassar Andromaco Skin Protectant, an OTC skin product that was found to be contaminated after high levels of yeast, mold, and bacteria were discovered.
Apr 20, 2018