Dr. Reddy’s Laboratories has received the final outcome of the United States Food & Drug Administration (USFDA) inspection at its Srikakulam, Andhra Pradesh facility. The inspection, which covered Pre-Approval and Good Manufacturing Practices (GMP), has been classified as ‘Voluntary Action Indicated (VAI)’. The company has been informed that the inspection is officially closed, indicating a favorable regulatory status for the unit.
USFDA Inspection Concludes at Srikakulam Unit
Dr. Reddy’s Laboratories Limited has announced the conclusion of the inspection conducted by the United States Food & Drug Administration (USFDA) at its FTO-SEZ Process Unit-02 located in Srikakulam, Andhra Pradesh. This inspection, which focused on Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP), took place earlier in the year. The company received communication regarding the inspection’s outcome on October 28, 2026.
Inspection Outcome: Voluntary Action Indicated (VAI)
The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated (VAI)’. This classification signifies that while observations may have been made, they do not warrant an Official Action Indicated (OAI) classification and are considered manageable by the company. Dr. Reddy’s Laboratories has been informed that the inspection process is officially closed, in accordance with relevant regulatory guidelines (21 CFR 20.64(d)(3)).
This update provides clarity on the regulatory standing of the Srikakulam manufacturing facility, which is a key operational asset for the company. The VAI classification is generally viewed favorably by the market as it suggests no significant impediments to the facility’s ongoing operations or product submissions.
Source: BSE
