Dr. Reddy's Srikakulam plant gets VAI status from USFDA, inspection now closed

New Delhi, Oct 21 Hyderabad-based pharmaceutical company Dr. Reddy’s Laboratories on Tuesday announced that its manufacturing facility in Srikakulam, Andhra Pradesh, has received a "Voluntary Action Indicated" (VAI) status from the US Food and Drug Administration (USFDA).

The company shared this information with the stock exchanges and said it received the Establishment Inspection Report (EIR) on October 20.

According to the company, the inspection by the USFDA is now officially closed. The VAI classification means that the US health regulator found some issues at the facility, but it does not plan to take any regulatory or administrative action at this time.

"We wish to inform you that the company has received the Establishment Inspection Report (EIR) on October 20, 2025. The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)'," it said, adding the inspection is officially closed.

This status is considered better than an "Official Action Indicated" (OAI), which could lead to stricter consequences such as warning letters or import alerts.

Earlier, Dr. Reddy’s had reported that the Srikakulam facility underwent both a Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) by the USFDA.

Following the news, shares of Dr. Reddy’s Laboratories closed 2.10 per cent higher at Rs 1,282.40 on Monday.

In the last five days, the shares have delivered a return of Rs 45.90 or 3.7 per cent. Over the past one month, the shares were down by Rs 16.40 or 1.26 per cent.

In the last six months, the shares have delivered a return of Rs 107.60 or 9.14 per cent. However, the stock remains down by around 6 per cent so far in 2025.

Over the past one year, the shares dropped by Rs 54.48 or 4.07 per cent, according to the official data.

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