Zydus Lifesciences has received the Establishment Inspection Report (EIR) from the USFDA for its injectable facility located at Jarod. The inspection, conducted from August 25 to September 5, 2025, classified the facility as Voluntary Action Indicated (VAI). This follows a previous warning letter issued on August 29, 2024. The receipt of the EIR indicates a positive outcome for the facility’s compliance and operational standards.
USFDA Issues EIR for Jarod Facility
Zydus Lifesciences announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) following a Good Manufacturing Practice (GMP) inspection at its injectable facility located in Jarod, Vadodara. The announcement was made on December 4, 2025.
Inspection Details and Classification
The USFDA conducted a follow-up inspection at the Jarod facility from August 25 to September 5, 2025. Following the inspection, the facility was classified as Voluntary Action Indicated (VAI). The inspection was initiated in response to a Warning Letter issued by the USFDA on August 29, 2024.
Source: BSE
