FORM 483, FDA WARNING LETTER AND RETROSPECTIVE STUDY OF WARNING LETTER ISSUED BY US FDA IN FISCAL YEAR 2019-2020

Main Article Content

M. S. JYOTHI
https://orcid.org/0000-0002-6257-1007
V. BALAMURALIDHARA
R. MAHALAKSHMI

Abstract

The United States is the world's largest pharmaceutical market. The US pharmaceutical industry, as the largest, most diverse and globalized industry, is the economy's most competitive and vital sector. Therefore, exporting to the US is a great opportunity that is leveraged by many nations, and to verify the quality standards of medicines, the US FDA was created. Since the inception of the US FDA, it has given numerous warning letters to pharmaceutical companies for violating regulatory guidelines. This paper provides the current environment of warning letters released by the US FDA from 2019 to 2020 and the FDA outlook (Food and drug administration) Effective corrective and preventive steps should be promptly corrected when issuing Form 483 and warning letters to guide the organization that there is a violation of 21 CFR (Code of Federal Regulations) / cGMP (current good manufacturing practices) on the premises.

Keywords:
FDA (Food and drug administration), form 483, warning letters, 21 CFR, United States

Article Details

How to Cite
JYOTHI, M. S., BALAMURALIDHARA, V., & MAHALAKSHMI, R. (2021). FORM 483, FDA WARNING LETTER AND RETROSPECTIVE STUDY OF WARNING LETTER ISSUED BY US FDA IN FISCAL YEAR 2019-2020. Journal of International Research in Medical and Pharmaceutical Sciences, 16(1), 26-33. Retrieved from https://ikprress.org/index.php/JIRMEPS/article/view/6224
Section
Review Article

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