Drug Approval | April 01, 2025
OneSource Specialty Pharma updates on cGMP inspection by USFDA
The inspection has concluded with four observations
The inspection has concluded with four observations
The Unit has been issued GMP Certification from ANVISA-Brazil
The company intends to respond to the two minor observations within the stipulated time
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
This is the second US FDA GMP inspection of this facility within one year
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection
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