USFDA clears Aurobindo’s North Carolina plant, warns another unit

The US Food and Drug Administration has issued a Voluntary Action Indicated (VAI) classification to Aurobindo Pharma's subsidiary Aurolife Pharma's plant in Raleigh, North Carolina, the company said on Monday. The VAI status means the facility's pending applications for inhalers and other dosage forms can now proceed through the FDA review process. The plant, which makes inhalers, dermatology and transdermal products, was inspected from March 24 to April 10, 2025, receiving 11 observations on a Form 483.

Separately, the FDA issued a warning letter to Aurobindo's wholly owned subsidiary Eugia Pharma Specialities Ltd's Unit-I in Telangana after an inspection found lapses in contamination controls, aseptic process validation and visual inspection of sterile drugs, including cases involving glass pieces in injection vials. The Times of India reports the warning followed the FDA's earlier classification of the facility as Official Action Indicated (OAI). The company said existing US supplies were not affected and the unit accounts for about 2% of group revenue.

The warning letter stems from a February 16-27 inspection that yielded four observations, including inadequate environmental monitoring in critical laminar airflow areas and failure to conduct aseptic process simulations since July 2022 for a drug product shipped to the US since March 2024. Aurobindo said it is committed to working closely with the FDA to enhance compliance.