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USFDA issues Form 483 with 5 observations to Aurobindo Pharma's Andhra unit

Aurobindo Pharma said the USFDA issued a Form 483 with five procedural observations after inspecting Unit-IV of its subsidiary APL Healthcare in Andhra Pradesh from December 817, 2025. The company said it will respond within stipulated timelines and remains committed to quality standards.

18 Dec 2025 1:42 pm