FDA warning letter · Drugs

Aurobindo Pharmaceutical Limited

Issued Jan 12, 2022 · Posted by FDA Jan 25, 2022

FDA published a close-out letter on Nov 17, 2025. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Failure to evaluate the potential effect that changes may have on the quality of your intermediates and API.

Passage 2
Failure of your quality unit to ensure that critical deviations are investigated and resolved.