FDA warns Chinese company for drug manufacturing data integrity violations

FDA警告宁波惠泽日化违反药品伪造数据完整性

2019-08-21 16:31:37 pharmamanufacturing

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The U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity, an over-the-counter drug manufacturer, for significant current good manufacturing practice violations, including data integrity issues. According to the FDA, the warning letter details Ningbo Huize's failure to have adequate quality control mechanisms in place. The company provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs. The firm also provided records showing they performed the required periodic reviews of their operation to assure quality, which they later admitted were also falsified. These CGMP violations cause all drugs manufactured by Ningbo Huize to be adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA also considers the adulterated products to be misbranded because the product labels did not include all the required information and directions for use. The labels of OTC medicines must comply with all requirements of the FD&C Act and applicable regulations. Following the inspection in March 2019, the FDA placed the company on import alert in June 2019 to prevent their drugs from entering the U.S. market. The company has also agreed to voluntarily recall drugs. The FDA requested a response from the company within 15 working days of receipt of the letter. The company is directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letter also states that failure to correct violations may result in the FDA continuing to refuse admission of products manufactured at the company’s facility. The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered.
美国食品和药物管理局( FDA )向非处方药生产商宁波惠泽日化公司发出警告信,称该公司目前存在严重的违反生产规范行为,包括数据完整性问题。 根据 FDA 的警告信,详细说明宁波慧泽未能建立足够的质量控制机制。该公司向 FDA 调查人员提供了多份伪造文件,包括多个药品的清洁验证报告和批生产和控制记录。该公司还提供了记录,表明他们对其业务进行了必要的定期审查,以确保质量,他们后来承认这些也是伪造的。这些违反 CGMP 的行为使得宁波慧泽生产的所有药品都被联邦食品、药品和化妆品法案所掺假。FDA 还认为,掺假产品被贴错了标签,因为产品标签没有包括所有必需的信息和使用指南。非处方药(OTC)药品的标签必须符合 FD & C 法案和适用法规的所有要求。经过2019年3月的检查, FDA 于2019年6月将公司置于进口警报状态,以防止其药品进入美国市场。公司还同意自愿召回药品。 FDA 要求公司在收到信件后15个工作日内做出回应。该公司被要求向该机构通报为解决该机构的每一个关切事项而采取的具体行动。警告信还指出,如果不纠正违规行为,可能会导致 FDA 继续拒绝接受该公司工厂生产的产品。 FDA 已经发现药物质量数据和信息不准确的情况,这可能掩盖问题和失败。当数据被改变时,病人无法保证他们的药物的安全性和有效性。

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