Abstract
USFDA is one the most regulated agency. The USFDA quality production office (OMQ) office at the Center for Drug Evaluation and Research (CDER) assesses compliance with drug cGMP based on test reports and evidence collected by USFDA investigators. The material described in the FDA warning letters may be the result of a subsequent communication between the FDA and the recipient of the book which may alter the regulatory nature of the discussions discussed in the publication. An FDA Form 483 is issued to strict supervisors upon completion of an examination once the investigator(investigators) has identified any circumstances in their judgment which may be a violation of the Food Drug and Cosmetic (FD & C) Act and related legislation. This study is about analysis on FDA warning letters in the year 2018,2019,2020 related to Manufacturing Quality and to comparison between India and other nations. This is to analyze that the issuance of warning letters related to manufacturing quality in India or among other nations is increasing or decreasing.
Conflict of Interest
The authors declare no conflict of interest.
Ethical Approval
Not applicable
Data Availability
The datasets used in this study are openly available at [repository link] and the source code is available on GitHub at [GitHub link].
Funding
This work did not receive any external funding.
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