Natco Pharma announces that its Pharma division in Kothur, Hyderabad, has received an Establishment Inspection Report (EIR) following an inspection by the U.S. Food and Drug Administration (FDA). The report classifies the facility as Voluntary Action Indicated (VAI). This update follows the inspection, providing important information to stakeholders regarding the facility’s compliance status.
Establishment Inspection Report Received
Natco Pharma has received the Establishment Inspection Report (EIR) for its Pharma division located in Kothur, Hyderabad, India. This follows an inspection conducted by the U.S. Food and Drug Administration (FDA). The company released this information on September 18, 2025.
Voluntary Action Indicated (VAI) Classification
The EIR classifies the facility as “Voluntary Action Indicated (VAI)”. This means that while some observations were made during the inspection, the FDA will not take further regulatory action at this time. This classification provides clarity regarding the facility’s operational status and compliance standing following the FDA’s review.
Source: BSE
