The US Food and Drug Administration (FDA) has discovered new issues at Aurobindo Pharma, India’s second-largest drugmaker.
During a recent visit to an Aurobindo facility in Anakapalli, eastern India, FDA auditors found deficiencies in manufacturing equipment cleaning and storage controls. They also uncovered unapproved changes to the manufacturing process and inadequate documentation.
Aurobindo has faced multiple problems in recent years. In 2019, the FDA banned imports of certain generic drugs from Aurobindo’s Indian facilities due to quality control issues. The Securities and Exchange Commission (SEC) has also been investigating the company for potential accounting irregularities.
These recent FDA findings could further harm Aurobindo’s reputation and lead to additional restrictions on its drug exports to the United States. The company has expressed its commitment to addressing the FDA’s observations and is taking corrective actions.
The FDA’s findings highlight the challenges that Indian drugmakers face in meeting the stringent standards of the US market. Several high-profile cases of substandard or contaminated drugs from Indian manufacturers have raised concerns about the safety of Indian-made drugs and triggered increased FDA scrutiny.
The impact of the latest FDA findings on Aurobindo’s business remains uncertain. However, the company is expected to encounter challenges as it works to resolve the problems identified by the FDA.
