Drug major

药品巨头

Sun Pharma

太阳制药

on Saturday said the US health regulator has issued a Form 483 with 8 observations after inspecting its Halol (Gujarat) manufacturing plant.

周六表示，美国健康监管机构在检查其位于古吉拉特邦哈洛尔的制造工厂后，发出了包含8项观察意见的483表格。

The US Food and Drug Administration (USFDA) conducted a good manufacturing practices (GMP) inspection at the Halol facility from June 2-13 2025, the Mumbai-based drug maker said in a regulatory filing.

美国食品药品监督管理局 (USFDA) 于 2025 年 6 月 2 日至 13 日对 Halol 工厂进行了良好生产规范 (GMP) 检查，这家总部位于孟买的制药商在监管文件中表示。

At the conclusion of the inspection, the USFDA issued a Form-483 with 8 observations, it added.

在检查结束时，美国食品药品监督管理局（USFDA）发出了包含8项观察意见的483表格，它补充道。

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

根据美国食品药品监督管理局（USFDA）的规定，当调查人员在检查过程中发现任何可能构成违反《食品、药品和化妆品法案》（FD&C法案）及相关法案的情况时，将在检查结束时向公司管理层发出483表格。

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