FORM 483, FDA WARNING LETTER AND RETROSPECTIVE STUDY OF WARNING LETTER ISSUED BY US FDA IN FISCAL YEAR 2019-2020
M. S. JYOTHI
*
Regulatory Affairs Branch, Department of Pharmaceutics, JSS College of Pharmacy Sri Shivarathreeshwara Nagara, Mysuru – 570015, India.
V. BALAMURALIDHARA
Regulatory Affairs Branch, Department of Pharmaceutics, JSS College of Pharmacy Sri Shivarathreeshwara Nagara, Mysuru – 570015, India.
R. MAHALAKSHMI
Regulatory Affairs Branch, Department of Pharmaceutics, JSS College of Pharmacy Sri Shivarathreeshwara Nagara, Mysuru – 570015, India.
*Author to whom correspondence should be addressed.
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