Report Links Data Integrity Issues to Drug Manufacturing Overseas

There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities.

That’s the conclusion of a report unveiled last week from PricewaterhouseCoopers’ Health Research Institute that shows that the number of warning letters involving data integrity issues has soared since 2010, with only one issued that year versus 10 in 2015.

The report notes that an overwhelming majority of these are going to foreign facilities: 28 of the 29 warning letters citing data integrity problems that were issued between 2010 and 2015 went to non-U.S. companies. Of those, 18 went to companies in India, six to Chinese manufacturers, two to Italian companies and one each for manufacturers in the United Arab Emirates and Thailand.