Drug Approval | February 21, 2025
Lupin receives EIR from USFDA for its Somerset manufacturing facility
the inspection conducted from January 27 to January 31, 2025
the inspection conducted from January 27 to January 31, 2025
OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The facility is a part of Lupin Manufacturing Solutions
Subscribe To Our Newsletter & Stay Updated
