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# Lawyer Slams FDA on Foreign Drug Quality Enforcement
- URL: https://www.fdaweb.com/lawyer-slams-fda-on-foreign-drug-quality-enforcement/
- Published: 2016-08-11T12:00:00.000Z
- Updated: 2026-09-14T21:24:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136478

Attorney **Mark Schwartz** (Hyman, Phelps & McNamara) says it is “troubling that FDA has been so delinquent in developing a framework to more objectively assess the strength of quality systems throughout the \[drug\] industry, which could have identified such problems in their infancy, and done so more accurately.” Schwartz’ comment in an online *FDA Law Blog* [post](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2016/08/assessing-the-fdas-safety-drive.html?utm%5Fsource=feedburner&utm%5Fmedium=email&utm%5Fcampaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29) relates to the rapidly increasing number of data integrity issues seen particularly in foreign facilities manufacturing finished drugs and active pharmaceutical ingredients.

He says that many agency Warning Letters issued for egregious manufacturing practices, especially in India and China, “paint a grim picture of the safety of the drug supply, as a disturbingly large percentage of the facilities in question are alleged to have ‘data integrity’ violations, meaning that FDA believes that the records kept as evidence of the safety of the manufactured products have been manipulated in some way. This is significant because approximately 40% of drugs sold in the U.S. are made outside the country, as are 80% of the active pharmaceutical ingredients used in these drugs. An increasing fraction of these are sourced from India and China.”

According to Schwartz, examples of data integrity problems seen in inspections include the repeated testing of products until they are deemed to meet the threshold specifications, the destruction and falsification of laboratory data, the blending of out-of-specification batches of drug product with batches that meet specifications, the backdating or predating of lab records, and the failure to implement measures preventing the manipulation, deletion, or overwriting of electronic data.

“FDA representatives have long acknowledged publicly that the agency hasn’t had an objective method for measuring quality in the drug industry,” the post says. “At which facilities are manufacturing procedures improving? By how much and in what way? Last year, finally recognizing that one cannot effectively improve what one cannot measure, the agency released a public document on quality metrics. When finalized, it might allow for a comprehensive assessment of quality across the industry. It is based on data submitted to FDA by drug firms…. Also, the agency’s New Inspection Protocol Project, for which no substantive documents have been issued, seeks to use semi-quantitative scoring on inspections to allow FDA to make comparisons among facilities manufacturing similar products. It would also compare the results from within a facility over multiple inspections, with the goal of standardizing the inspection process.”

Schwartz says that stakeholders should participate fully in the FDA public consultation process on these activities to ensure that the intended objectives are achieved without imposing an undue burden on industry, and without foisting requirements on pharmaceuticals that exceed the agency’s legal authority. “Public health in the U.S. is at stake,” he concludes.