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Jinja, Bhumi K.
- A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021
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Authors
Ashok B. Patel
1,
Bhumi K. Jinja
1,
Amit Kumar J. Vyas
1,
Nilesh K. Patel
1,
Ajay I. Patel
1,
Devang B. Sheth
2,
Sunny R. Shah
1
Affiliations
1 Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, IN
2 L.M. College of Pharmacy, MG Science College Marg, Opp. Gujarat University, University Area, Ahmedabad – 380009 Gujarat, IN
1 Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dem, Bhavnagar Road, Rajkot – 360003 Gujarat, IN
2 L.M. College of Pharmacy, MG Science College Marg, Opp. Gujarat University, University Area, Ahmedabad – 380009 Gujarat, IN
Source
Asian Journal of Pharmaceutical Research, Vol 12, No 4 (2022), Pagination: 295 - 301Abstract
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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