A retrospective study of Warning Letters issued by US FDA over 2015-2017

  • Lakshmi Ananth The IIHMR University
  • Nirmal K. Gurbani
  • Saurabh Kumar The IIHMR University
  • Bharat Gujavarti


This paper provides contemporary climate of warning letters issued by US FDA over 2015 to 2017. With 1300$ Billion Revenue in 2017 United States stands as World’s largest Pharmaceutical Market. Being the largest, diversified and due to globalization, US Pharma industry is the most competitive and critical sectors of the economy. So, exporting to the US is a great opportunity which is leveraged by many countries and US FDA was formed to check the quality standards of Medicines. Since the inception of US FDA, it has been giving many warning letters to Pharmaceutical Companies for violating regulatory guidelines. The back bone of this paper is to analyse warning letters and to identify what are the major violations in case of Pharmaceuticals.

Keywords: Form 483, Warning Letters, Regulatory Affairs, Regulatory Environment, Adulteration, Labelling Issues, Misbranding, Misleading Claims, FDA Warning Letters


Download data is not yet available.


1. APEC. Life Sciences Innovation Forum [Internet]. Asia-Pacific Economic Cooperation; 2017 [cited 2018 Mat 05]. Available from:
2. ITA. 2016 Top Markets Report Pharmaceuticals. United States: International Trade Administration; 2016.
3. Services. U. D. What We Do. [Internet]. US FDA; 2017 Dec 29 [cited 2018 May 05]. Available from:
4. Charles Preston M M. FDA and Pan American Partners Work to Strengthen Regulatory Systems [Internet]. US FDA; 2014 May 28 [cited 2018 May 05]. Available from:
5. Services, U. D. FDA Basics: When and Why FDA was formed? [Internet]. US FDA; 2018 Mar 07 [cited 2018 May 05]. Available from:
6. FDA. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies [Internet]. FDA; 2018 [cited 2018 May 05]. Available from: https://tinyurl.com/ydhmffky
806 Views | 1505 Downloads
How to Cite
Ananth, L., N. K. Gurbani, S. Kumar, and B. Gujavarti. “A Retrospective Study of Warning Letters Issued by US FDA over 2015-2017”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 48-53, doi:10.22270/ijdra.v6i2.242.