美国林业发展局在Piramal Pharma的印度工厂发现四个程序问题;公司承诺合作和遵守规定。 U.S. FDA found four procedural issues at Piramal Pharma’s Indian plant; company vows cooperation and compliance.

美国林业发展局在2026年2月9日至13日对印度Telangana的Piramal Pharma的Digwal工厂进行视察时发布了一份表格483, 附有四条意见。 The U.S. FDA issued a Form 483 with four observations during an inspection of Piramal Pharma’s Digwal plant in Telangana, India, from February 9 to 13, 2026. 调查结果涉及程序上的改进,而不是数据的完整性,被归类为 " 自愿行动 " 。 The findings, related to procedural improvements rather than data integrity, are classified as Voluntary Action Indicated. Piramal Pharma说,它正在准备在规定时限内提交答复,重申对遵守规定和质量的承诺,保证与林业发展局密切合作解决这些问题。 Piramal Pharma said it is preparing a response to submit within the required timeframe and reaffirmed its commitment to compliance and quality, pledging close cooperation with the FDA to address the issues.