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Lannett's Indiana Facility Receives Four FDA Observations in Inspection

Lannett’s Seymour manufacturing plant in the US received four observations from the FDA, highlighting areas for compliance improvement.

Methly Agarwal | | 1 min read

Lannett's Indiana Facility Receives Four FDA Observations in Inspection
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In Brief

  1. Lannett Company LLC (Aurobindo Pharma’s U.S. subsidiary) received four procedural observations after an FDA inspection (Aug 17–21, 2026) in Seymour, Indiana.
  2. Aurobindo confirmed the issues are procedural and will respond within the required timeline.
  3. The Seymour plant is a major site producing ~4 billion doses annually for the U.S. generic market.

Aurobindo Pharma’s U.S. subsidiary, Lannett Company LLC, received four observations from the U.S. Food and Drug Administration (FDA) following a routine inspection of its manufacturing facility in Seymour, Indiana. The inspection took place from August 17 to 21, 2026. The FDA’s observations pertain to procedural and compliance issues. Although specific details were not publicly released, Aurobindo Pharma described them as procedural in nature and confirmed it will respond within the required timeline.

The Seymour facility is a key manufacturing site for Lannett, capable of producing approximately 4 billion doses annually to support the supply of generic medicines to the U.S. market. As part of Aurobindo Pharma’s broader U.S. operations, Lannett plays a significant role in the Indian drugmaker’s expansion in the American pharmaceutical market. Aurobindo reaffirmed its commitment to maintaining strong quality, manufacturing, and regulatory compliance standards across all its facilities.



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