Author(s): Ashok B. Patel, Bhumi K. Jinja, Amit Kumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth, Sunny R. Shah

Email(s): bhumijinja243@gmail.com

DOI: 10.52711/2231-5691.2022.00048   

Address: Ashok B. Patel1, Bhumi K. Jinja1*, Amit Kumar J. Vyas1, Nilesh K. Patel1, Ajay I. Patel1, Devang B. Sheth2, Sunny R. Shah1
1Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India.
2L.M. College of Pharmacy, MG Science College Marg, Opp. Gujarat University, University Area, Ahmedabad – 380009 Gujarat, India.
*Corresponding Author

Published In:   Volume - 12,      Issue - 4,     Year - 2022


ABSTRACT:
The United States Food and Drug Administration (US FDA) is a department of health and human services federal agency. If the FDA notices major violations of federal regulations, it sends warning letters to pharmaceutical makers, distributors, and clinical investigators. The nature of the infractions discovered, as well as the FDA's proposed corrective activities, are detailed in these warning letters. Following the completion of the corrective activities, the recipient may request a follow-up inspection. This review article examines the current state of warning letters issued by the US Food and Drug Administration (FDA) from 2019 to 2021. The main goal of this study is to examine warning letters related to drug and determine what the significant violations.


Cite this article:
Ashok B. Patel, Bhumi K. Jinja, Amit Kumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth, Sunny R. Shah. A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021. Asian Journal of Pharmaceutical Research 2022; 12(4):295-1. doi: 10.52711/2231-5691.2022.00048

Cite(Electronic):
Ashok B. Patel, Bhumi K. Jinja, Amit Kumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth, Sunny R. Shah. A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021. Asian Journal of Pharmaceutical Research 2022; 12(4):295-1. doi: 10.52711/2231-5691.2022.00048   Available on: https://asianjpr.com/AbstractView.aspx?PID=2022-12-4-7


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