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Aurobindo Pharma shares drop 4% after US FDA flags lapses at Unit-7The US FDA had inspected Aurobindo's Unit-7 between January 28 and February 10, 2026. The inspection observations pointed to multiple lapses in manufacturing and quality control processes.By Meghna Sen  February 18, 2026, 11:46:56 AM IST (Updated)2 Min ReadShares of Aurobindo Pharma Ltd. declined as much as 4% in Wednesday's trading session after details from the Form 483 issued to its Unit-7 facility were accessed.

The US FDA had inspected Aurobindo's Unit-7 between January 28 and February 10, 2026. The inspection observations pointed to multiple lapses in manufacturing and quality control processes.

According to the Form 483, equipment and utensils were not cleaned at regular intervals, and adequate controls were not exercised over computer systems.

Master manufacturing records lacked proper manufacturing and control instructions, while complaint records did not include investigation findings or follow-up actions.

The FDA also flagged failure to review unexplained discrepancies and non-adherence to quality control procedures.

In a serious observation, a microbiologist responsible for sample collection was found to have falsified sample collection data.

Lab records were described as deficient, with established laboratory mechanisms not being followed. The regulator also cited that GMP training was not conducted on a continuous basis.

The observations raise concerns over compliance standards at the facility and potential risks to Aurobindo's US business.

The Form 483 flagged issues including alleged record falsification and deletion, the presence of E. coli and bird droppings at the unit, and low-risk assessments assigned to complaints originating from US markets since 2026.

Analysts remain divided in their assessment of the US FDA observations.

Some argue that certain observations, particularly Observation 6, raise data integrity concerns. The observation states that a microbiologist may have falsified sample collection data.

Given the seriousness of this issue, they believe an escalation to Official Action Indicated (OAI) status or even a Warning Letter cannot be ruled out.

Others view the observations as largely procedural in nature, with no material concerns around patient safety or systemic data integrity.

While they acknowledge that OAI cannot be entirely ruled out, they see Voluntary Action Indicated (VAI) as the more likely outcome. They also consider the probability of an escalation to an import alert to be low.Continue ReadingFirst Published: Feb 18, 2026 11:31 AM ISTTagsAurobindo PharmaAurobindo Pharma USFDAshare market today