美国食品药品管理局向广东三家药企发出警告信：两家已被列入进口警报、一家防晒产品使用已取消的着色剂
华盛顿——美国食品药品管理局（FDA）药品审评与研究中心 10 月 26 日至 27 日接连向三家位于广东的非处方药生产企业发出警告信，指其成品药生产不符合现行药品生产质量管理规范（CGMP）等要求，相关产品依法被认定为「掺假」药品。三封警告信本周在 FDA 官网公开，企业须在收到信后 15 个工作日内书面回复整改方案。
三家企业中，位于汕头市潮南区司马浦镇的广东邦泽药业有限公司（Guangdong Bangze Medicine Co., Ltd.）于 10 月 26 日收到警告信（编号 320-27-10）。FDA 在按《联邦食品、药品和化妆品法》第 704(a)(4) 条调阅其提交的记录后认定其成品药生产存在重大 CGMP 违规；早在今年 8 月 7 日，FDA 已把该公司全部药品列入 66-40 号进口警报。
位于肇庆市下茅镇的广东必速康生物科技有限公司（Guangdong Bisutang Biotechnology Co., Ltd.）于 10 月 27 日收到警告信（编号 320-27-11）。该公司登记生产包括防晒产品在内的非处方药；FDA 认定其「XUEYI SKIN CARE」防晒产品使用了已被取消的着色剂 Ext. D&C Yellow No. 5，按法律该着色剂不安全，产品因此被认定为掺假。该公司全部药品已于今年 7 月 31 日被列入 66-79 号进口警报。
位于广州市白云区的广州九功科研生物科技有限公司（Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.）同日收到警告信（编号 320-27-13）。FDA 在调阅记录后认定其生产存在重大 CGMP 违规，并指出其产品使用了已被取消的着色剂 FD&C Red No. 2。
FDA 在信中警告，若企业不纠正违规，FDA 可能继续拒绝其产品进入美国市场，并可能暂缓批准把该企业列为生产商的新药申请。进口警报意味着相关产品在入境时可被直接扣留、无需逐批检验。
按 FDA 的公开记录，这三封信都源于该机构对境外药厂提交记录的书面审查，而非赴厂现场检查。广东是中国非处方药与化妆品生产集中的省份之一，这三家企业的产品此前均已登记在 FDA 的药品目录中面向美国市场销售。
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.
来源：美国食品药品管理局
发布：GSM·美国（发布链接）
图片来源：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.
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