U.S. FDA’s VAI tag for Dr. Reddy’s unit in Srikakulam, inspection closed

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Published - October 28, 2026 10:20 pm IST - HYDERABAD

The U.S.

Food and Drug Administration (U.S.

FDA) has classified Dr.

Reddy’s Laboratories facility in Srikakulam, Andhra Pradesh, post an inspection, as Voluntary Action Indicated (VAI).

The regulator had issued a Form 483 with three observations following the PreApproval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of the FTO-SEZ Process Unit-02 in Srikakulam between July 20 and July 29.

“We wish to inform the U.S.

FDA has classified the inspection outcome as ‘voluntary action indicated (VAI)’ and concluded that the inspection is officially closed,” Dr.

Reddy’s said in a filing on Wednesday.

One of three classifications the U.S.

FDA issues, post inspection of pharma facilities, VAI means while objectionable conditions or practices were found, the regulator is not prepared to take or recommend any administrative or regulatory action.

Under OAI, another classification, the U.S.

FDA recommends regulatory and/or administrative actions.

The third classification is No Action Indicated (NAI) and conveys that no objectionable conditions or practices were found during the inspection.

business (general) / pharmaceutical / medicine

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