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MFCI Research Institute
MFCI Research Institute
REGULATIONS
Regulatory Certification
FDA Audit
The United States has always been an important product market for MFCI, and FDA audits are recognized as the most authoritative certification in the industry.
MFCI began submitting DMF files to the U.S. FDA in 2007. In 2014, MFCI(Huanggang) passed its first FDA audit.
Currently, the GMP system fully complies with ICH Q7 requirements, while two internal audits are conducted annually to ensure continuous improvement of the GMP system.
In 2024, Hubei Meikai passed its second FDA audit.
Address: Room 2501, Block B, Wanda Office Building, 30 Huahu Avenue, Huangshi City, Hubei Province
Telephone: 86-714-6516706
E-mail:sales@mfci.com.cn
