Aditi S. Thakur

FDA/CDER/OPQ/OPF
Acting Quality Assessment Lead
Aditi S. Thakur, M.S. joined the FDA, Office of Process and Facilities in 2015 as a chemist, where she performs pre-approval assessment of submissions and participated on Preapproval Inspections (PAIs). Currently she is working as a Quality Assessment lead in Office of Pharmaceutical Quality in the sub Office of Process and Facilities. Prior to the FDA, she worked in two separate cGMP complaint specialty pharmaceuticals companies involving complex soft gelatin and inhalation dosage forms. Aditi earned a M.S. in Industrial Pharmacy from Long Island University, NY. Aditi is responsible for primary and secondary review of Process and Facility reviews for the submissions. Aditi has been involved in various data integrity cases in collaboration with other offices within the Agency. Aditi’s interests include data Integrity evaluation of the submissions, regulatory manufacturing risk assessment, and complex manufacturing processes and dosage forms.