FDA Issues Warning Letters to Three Guangdong Drugmakers: Two Already Under Import Alerts, One Sunscreen Used a Cancelled Color Additive
Washington — The Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued warning letters on October 26 and 27 to three over-the-counter drug manufacturers in China's Guangdong Province, finding significant violations of current good manufacturing practice (CGMP) requirements and deeming their finished drug products adulterated under federal law. The three letters were posted on the FDA website this week; each company must respond in writing within 15 business days with a remediation plan.
Guangdong Bangze Medicine Co., Ltd., based in Simapu Town, Chaonan District, Shantou, received its letter on October 26 (reference 320-27-10). Reviewing records the company submitted under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, the FDA cited significant CGMP violations for finished pharmaceuticals. The agency had already placed all of the company's drugs on Import Alert 66-40 on August 7 of this year.
Guangdong Bisutang Biotechnology Co., Ltd., based in Xiamao Town, Zhaoqing, received its letter on October 27 (reference 320-27-11). The company is registered to make over-the-counter products including sunscreen. The FDA determined that its “XUEYI SKIN CARE” sunscreen bears a cancelled color additive, Ext. D&C Yellow No. 5, which is unsafe within the meaning of the law, rendering the product adulterated. All of the company's drugs were placed on Import Alert 66-79 on July 31.
Guangzhou Jiugong Research and Development Biotechnology Co., Ltd., in Guangzhou's Baiyun District, received its letter the same day (reference 320-27-13). The FDA found significant CGMP violations in records the company submitted and cited its use of the cancelled color additive FD&C Red No. 2.
In the letters, the FDA warned that failure to correct the violations could lead it to keep refusing admission of the companies' products into the United States and to withhold approval of new applications listing them as manufacturers. Placement on an import alert means products can be detained at the border without physical examination.
According to the FDA's published letters, all three actions grew out of written reviews of records submitted by the foreign facilities rather than on-site inspections. Guangdong is one of China's main production bases for over-the-counter drugs and cosmetics, and all three companies had products listed with the FDA for sale in the U.S. market.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品管理局（FDA）位于马里兰州 Silver Spring 的 White Oak 园区大楼。照片：美国食品药品管理局，公有领域，经 Wikimedia Commons。 / Photo: A U.S. Food and Drug Administration building at the White Oak campus in Silver Spring, Maryland. Photo by the U.S. Food and Drug Administration, public domain, via Wikimedia Commons.
