Three Foreign Manufacturers Get FDA Form 483s

In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers.

The reports were for Laurus Synthesis of Ankapalli, Andhra Pradesh; Torrent Pharmaceuticals of Chhatral, Gujurat; and Dr. Reddy’s Laboratories of Bachupally, Medchal-Malkajgiri, Telangana, for inspections conducted in early December.

The 483s come as the agency struggles to clear the logjam of foreign inspections that stacked up during the COVID-19 pandemic, when travel restrictions and regional lockdowns impaired the FDA’s ability to visit plants. According to a Health Affairs study published in November, drug quality assurance inspections are still far below pre-pandemic rates.

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