Natco Pharma's Kothur Unit Inspection: A Step Closer to Compliance

Natco Pharma Ltd's Kothur unit in Hyderabad received an 'Establishment Inspection Report' from the US FDA, classified as 'voluntary action indicated.' This means while some issues were found during inspection, no regulatory action will be taken.

Natco Pharma Ltd. recently received an important update from the US health regulator regarding its Kothur unit in Hyderabad. The US Food and Drug Administration (FDA) issued an Establishment Inspection Report (EIR) classifying the facility as 'Voluntary Action Indicated' (VAI).

The inspection conducted at the company's pharmaceutical division led to the discovery of objectionable conditions, which were documented by the agency.

However, under the VAI classification, the FDA has opted not to take or recommend any regulatory action at this time, allowing Natco Pharma to address the issues independently.

(With inputs from agencies.)