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# Foreign Data Integrity Violations Up: Analysis
- URL: https://www.fdaweb.com/foreign-data-integrity-violations-up-analysis/
- Published: 2016-03-29T12:00:00.000Z
- Updated: 2026-09-14T20:51:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135208

> Since 2010, FDA has issued Warning Letters to an increasing number of companies for data integrity violations, according to an analysis by the PricewaterhouseCoopers Health Research Institute, [reported](https://www.pwc.com/us/en/healthcare/assets/pwc-data-integrity-spotlight.pdf?ref=fdaweb.com) in a March *Regulatory Spotlight*. From 2010 to 2012, it says, five drug manufacturers were cited for data integrity violations, while from 2013 to 2015, 24 companies were. “During this time period,” the report says, “the three most common issues cited were a lack of controls to prevent alterations of data by staff, a failure to maintain records of accurate data, and delayed reporting of data.”  
>  
> The analysis found that a disproportionate number of violations occurred in facilities located outside the U.S. Thus, of the 29 Warning Letter sent to drug manufacturers about data integrity problems, 18 went to companies with facilities based in India and six in China. Only one U.S.-based facility received a letter, despite the fact that U.S. facilities were the subject of 68.8% of all FDA global drug quality inspections between 2010 and 2015.  
>  
> The report lists these implications for industry:  
> as FDA expands its global presence, more companies may find their foreign manufacturing operations being scrutinized, meaning that companies should audit global subsidiaries and partners to ensure that their supply chains adhere to data integrity principles and practices; data integrity violations can lead to import bans, recalls, public warnings, detained products, delayed or denied drug approvals, lawsuits, lost business, and costly remediation efforts; and companies should focus on technology to defend against problems.