Dr. Reddy’s Laboratories announced the conclusion of the United States Food & Drug Administration (USFDA) inspection at its Srikakulam formulations manufacturing facility (FTO-SEZ PU01). Following the Pre-Approval Inspection (PAI) initially intimated in December 2025, the company received the Establishment Inspection Report (EIR) on March 04, 2026. The USFDA classified the inspection outcome as ‘Voluntary Action Indicated (VAI)’, officially closing the matter.
Favorable Outcome for Manufacturing Facility
Dr. Reddy’s Laboratories has provided an update regarding the inspection conducted by the United States Food & Drug Administration (USFDA) at its formulations manufacturing facility located in Srikakulam, Andhra Pradesh (Facility Code: FTO-SEZ PU01).
The inspection, which followed a Pre-Approval Inspection (PAI) initiated on December 12, 2025, has now been formally closed. The company confirmed receiving the Establishment Inspection Report (EIR) on March 04, 2026.
Inspection Classification Details
The USFDA has assigned a classification of ‘Voluntary Action Indicated (VAI)’ to the inspection outcome. This classification signifies that the agency has concluded the inspection and determined that the facility’s compliance status requires voluntary corrective actions from the company, as opposed to mandatory enforcement.
The communication confirms that the inspection is officially closed under the relevant regulatory provisions, providing certainty for the manufacturing operations at the site.
Source: BSE
