Gland Pharma announced that the issuance of an EIR for their Vishakhapatnam facility by the US FDA

Gland Pharma announced that the issuance of an EIR for their Vishakhapatnam facility by the US FDA indicates that the agency has found the facility to be in an acceptable state of compliance with its Current Good Manufacturing Practice (cGMP) regulations. 

An Establishment Inspection Report (EIR) from the US FDA is a document issued to a company after inspecting its facility, indicating that the inspection has been closed. EIRs are of three types: No Action Indicated (NAI), Voluntary Action Indicated (VAI), and Official Action Indicated (OAI).

EIR from the USFDA for Gland Pharma's Visakhapatnam facility shows a "Voluntary Action Indicated" (VAI) status. This indicates that the USFDA has accepted the company's response to inspection observations and considers the issues resolved through voluntary corrective actions. 


The facility at Vishakhapatnam supplies sterile APIs for FDF manufacturers and its own ANDAs at Gland Pharma. This inspection closure will ensure the continued supply of sterile APIs to ANDAs. 





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