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A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021


Affiliations
1 Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India
2 L.M. College of Pharmacy, MG Science College Marg, Opp. Gujarat University, University Area, Ahmedabad – 380009 Gujarat, India
     

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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.


Keywords

Form no 483, Warning Letters, Violation, cGMP, Close-out letter
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  • A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021

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Authors

Ashok B. Patel
Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India
Bhumi K. Jinja
Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India
Amit Kumar J. Vyas
Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India
Nilesh K. Patel
Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India
Ajay I. Patel
Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India
Devang B. Sheth
L.M. College of Pharmacy, MG Science College Marg, Opp. Gujarat University, University Area, Ahmedabad – 380009 Gujarat, India
Sunny R. Shah
Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, India

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.


Keywords


Form no 483, Warning Letters, Violation, cGMP, Close-out letter

References