Aurobindo Pharma Shares Plunge on US FDA's Nine Serious Observations

rma's shares tumbled as much as 5% on February 18, 2026, hitting a low of Rs 1,129.20, breaking a recent two-session gain. The decline followed reports detailing nine significant observations by the US Food and Drug Administration (US FDA) at its Unit 7 oral solid dosage manufacturing facility in Telangana (Jedcherla). The FDA's inspection, conducted from January 28 to February 10, 2026, resulted in a Form 483 highlighting critical issues, including poor sanitation, inadequate equipment cleaning (some reportedly untouched for years), cross-contamination exceeding limits by 380 times, presence of E. coli, bird droppings in systems, data integrity lapses (including alleged falsification by a microbiologist), and deficiencies in quality controls, documentation, and complaint handling. Unit 7 is vital, supporting about 20% of Aurobindo’s US portfolio with over 150 ANDA filings. The findings raise concerns over potential delays in approvals and supplies to the key US market. The company has stated the observations are procedural and will respond within timelines. However, the severity — especially contamination and data issues — has heightened investor worries amid ongoing regulatory scrutiny on Indian pharma firms.