Investigation Details
Malgorzata Norton, MS , Zainab Mansaray-Storms, PhD , Parmesh Dutt , Evi Struble, PhD , Lu Deng, PhD , Jun Lee, PharmD/PhD , Hailing Yan, MS , Xiaofei Wang, PhD , Frantisek Bizik, PhD , Varsha Garnepudi , Erin Hill , Emnet Yitbarek , Xiuju Lu , Olga Simakova, PhD , Pei Zhang, MD , Sairah Thommi, MD , Luisa Virata , Parmesh Dutt, PhD , Jianping Li, PhD , Yambasu Brewah, PhD , Nancy Eller, MHS , Anil Choudhary, PhD , Jing Lin , Sarah Frasure, MD , Lisa Pham , Tao Pan , Emnet Yitbarek, PhD , Maria Virata, PhD , Lilin Zhong, MS , Jie He , Jennifer Reed, PhD , Claire Wernly, PhD , Afsah Amin, MD, MPH , Hyesuk Kong , Julia Wright, MHA, RN , Triparna Poddar, PhD , Kam Sang Kwok, PhD , Jing Lin, PhD , Jennifer Chan, PharmD
483s Issues in Countries
Form 483 Issued by Year
Top 5 Sub-Systems
No data available for top subsystems.
Top 5 Co-Investigators
Investigator Analysis
George Kastanis is a detail-oriented FDA investigator who places a strong emphasis on GMP compliance and quality systems in drug substance and product manufacturing. He is particularly concerned about adherence to standard manufacturing protocols and the adequacy of quality control testing.
George Kastanis'' approach focuses on meticulously scrutinizing GMP compliance, quality systems, and manufacturing protocols. He prioritizes the identification of deficiencies and potential risks to product safety and efficacy during inspections.
Form 483s Issued
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