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The Hindu·2 min read·medium

Aurobindo arm Lannett’s facility in U.S. gets 4 U.S. FDA observations

T
The Hindu Bureau
Aurobindo arm Lannett’s facility in U.S. gets 4 U.S. FDA observations
AI Summary

The US FDA issued four procedural observations to Lannett Company, a subsidiary of Aurobindo Pharma, following an inspection of its Indiana manufacturing facility. Aurobindo Pharma stated it has responded to the findings and remains committed to quality standards.

Why it matters

Regulatory scrutiny of pharmaceutical manufacturing facilities is critical for ensuring drug safety and maintaining supply chain reliability for the US market.

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The U.S. Food and Drug Administration (FDA) has issued four observations to Lannett Company LLC, a U.S. subsidiary of Aurobindo Pharma, following a routine inspection of its manufacturing facility in Seymour, Indiana.

The inspection was conducted from August 17 to 21 and concluded with four observations, which the company described as procedural in nature. Aurobindo Pharma said it has responded to the observations within the stipulated timeline and remains committed to maintaining robust quality and compliance standards across its manufacturing facilities.

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