Dr. Reddy's Laboratories Receives USFDA VAI Classification for Srikkulam Facility
Dr. Reddy's Laboratories received the USFDA Establishment Inspection Report on March 04, 2026, with a VAI classification for its Srikkulam formulations manufacturing facility. The inspection has been officially closed under 21 CFR 20.64(d)(3), following a GMP and Pre-Approval Inspection that was initially disclosed in December 2025. The VAI classification allows continued operations while addressing identified concerns voluntarily.
*this image is generated using AI for illustrative purposes only.
Dr. Reddy's Laboratories has received regulatory clearance from the United States Food & Drug Administration (USFDA) for its formulations manufacturing facility in Srikkulam, Andhra Pradesh. The pharmaceutical company announced on March 5, 2026, that it has received the Establishment Inspection Report (EIR) with a favorable outcome.
USFDA Inspection Outcome
The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)' and concluded that the inspection is officially closed under 21 CFR 20.64(d)(3). The company received the EIR on March 04, 2026, marking the completion of the regulatory review process.
| Parameter: | Details |
|---|---|
| Facility: | FTO-SEZ PU01, Srikkulam, Andhra Pradesh |
| Inspection Type: | GMP and Pre-Approval Inspection (PAI) |
| Classification: | Voluntary Action Indicated (VAI) |
| EIR Received: | March 04, 2026 |
| Status: | Officially closed under 21 CFR 20.64(d)(3) |
Background and Timeline
The inspection process began earlier when the USFDA conducted a GMP and Pre-Approval Inspection at Dr. Reddy's formulations manufacturing facility in Srikkulam. The company had initially informed stock exchanges about this inspection on December 12, 2025, as part of its disclosure obligations under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Regulatory Significance
The VAI classification indicates that the USFDA found objectionable conditions during the inspection but determined that the issues do not meet the threshold for regulatory or administrative action. This classification allows the facility to continue operations while addressing any identified concerns voluntarily. The official closure of the inspection under 21 CFR 20.64(d)(3) provides regulatory certainty for the company's manufacturing operations at the Srikkulam facility.
Historical Stock Returns for Dr Reddys Laboratories
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +1.73% | +0.54% | +5.91% | +4.83% | +17.26% | +43.55% |
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