News | May 07, 2026
CARBOGEN AMCIS Shanghai site clears unannounced NMPA GMP inspection
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China
The audit was completed with zero critical and zero major observations
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
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