New Delhi
Aurobindo Pharma has reported that the US health authority has issued a Form 483 with five observations for its Andhra Pradesh Unit-IV. The inspection was carried out by the US Food and Drug Administration (USFDA) from December 8 to December 17, 2025, the company said in a regulatory filing on Thursday.
The Hyderabad-based drug maker said the observations are procedural in nature. “We will respond to the USFDA within the required timelines,” the company added. It also emphasized its commitment to maintaining high-quality standards across all its manufacturing facilities worldwide.
Form 483 is a document issued by the USFDA at the end of an inspection. It lists any conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act and related regulations. While it does not represent final enforcement action, it indicates areas that need attention and correction.
Following the announcement, Aurobindo Pharma shares saw a modest rise. On the Bombay Stock Exchange, the stock was trading 0.83 per cent higher at Rs 1,203 per share.
The company has assured that it will address the observations promptly, maintaining transparency with regulators and investors. Observers say such inspections are common for global drug manufacturers and usually focus on improving compliance rather than penalizing firms.