Drug Approval | April 13, 2024
USFDA completes inspection of Lupin's Dabhasa facility with no observations
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
The observations do not pose any risk to site's compliance standards or its business continuity
The plant is yet to start commercial operations
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023
The company is confident of addressing all the observations within the stipulated time
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
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