As concerns mount over the quality of the pharmaceutical supply chain, the Food and Drug Administration has released new data showing the agency inspected more manufacturing plants located in India during the past two fiscal years and found these facilities generally had more quality problems than sites located in the U.S. or the European Union.
Specifically, the FDA inspected 6% more plants in India while examining 4% fewer sites in the U.S. and 6% fewer in the European Union from fiscal year 2017 to fiscal year 2019. Meanwhile, using a simple scale of 1 to 10 to assess compliance with good manufacturing regulations, the average score for all sites globally in fiscal year 2019 was 7.4, which was not significantly different than the 7.5 seen in fiscal year 2018.
Looking at different regions, however, the report found notable differences. The FDA found manufacturing facilities in the EU had an average score of 7.7 and the U.S. notched 7.6. But China rated 7, and India and Latin America each managed 6.8, which statistically placed them lower than the global average. Nonetheless, all of the scores indicated what the FDA called an “acceptable level” of compliance, on average.