Drug Approval | July 27, 2025
Concord Biotech successfully completes Russian GMP inspection at its API facility
The inspection was conducted from July 22-25, 2025
The inspection was conducted from July 22-25, 2025
This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance
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
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