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# FDA Downgrades Foreign Inspections: Book
- URL: https://www.fdaweb.com/fda-downgrades-foreign-inspections-book/
- Published: 2019-06-19T12:00:00.000Z
- Updated: 2026-09-15T01:33:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144373

A month after FDA denied her allegations about deficient FDA inspections at foreign generic drug makers, investigative journalist and *Fortune* contributor **Katherine Eban**, went further during a 6/19 Webinar and produced slides showing disparities between agency inspections in India and those at domestic manufacturers. Author of the *New York Times* bestselling book *Bottle of Lies,* Eban told the Association of Healthcare Journalists event that she found it disturbing that FDA supervisors had downgraded the severity of 109 Indian inspection findings and regulatory action recommendations between 2013-2018, while only one domestic inspection was downgraded during this timeframe.

Eban said she discovered that FDA investigators visiting India-based plants were often recommending the most serious sanctions (official action indicated), “but the bureaucrats sitting back in Maryland were downgrading these.” Some of the reasons for downgrading the India inspection, which often resulted in an untitled letter from FDA instead of the more serious FDA Warning Letter, included:

- Firm appeared cooperative
- Firm used back-channel influence
- Excessive regulatory delay by FDA

Eban also showed a 2013 email from an FDA supervisor questioning why a recommendation to place a Hospira India plant on import alert and issue a Warning Letter was overruled. The email said several FDA staff were upset that the “entire compliance review process has been undermined... and decisions are no longer based on science, policies and regulations, but politically motivated.”

Eban also shared a viewpoint from an FDA investigator and his/her experience with India manufacturing inspections: “All those products were failing dissolution, all of them. You submit this to FDA, they don’t quite understand the significance, they think, they have a good set of data, and when you talk about, should we recall these products forcefully? They never will. Zero times. The drugs are not good.... There is somebody in the agency that does not like to frighten patients. That’s the main thing, they do not want to cause panic. \[If people actually understood\] then no one would take \[these drugs\]. All you have to tell is one story. Pick any of the inspections.”

Eban’s book hit the shelves last month and FDA preemptively asserted that the quality of the U.S. drug supply is the best it has ever been. Addressing a [CBS News report ](https://www.cbsnews.com/news/generic-drugs-manufactured-overseas-may-not-be-as-safe-as-you-think/?ref=fdaweb.com)that featured Eban and her then-upcoming book, CDER Office of Pharmaceutical Quality director [**Michael Kopcha said**](https://www.fda.gov/drugs/news-events-human-drugs/cder-conversation-assuring-drug-quality-around-globe?utm%5Fcampaign=New%20CDER%20Conversation%3A%20Assuring%20Drug%20Quality%20Around%20the%20Globe&utm%5Fmedium=email&utm%5Fsource=Eloqua) in an online post that there is “no difference in the quality of drugs based only on where they are made... We use the same tools to assure quality whether a drug is manufactured in the United States or abroad. We apply the same quality standards and conduct the same inspections of manufacturing facilities regardless of where they are located – and we inspect all over the globe.”

Kopcha said that some “regions of the globe do have somewhat higher levels of violations found during inspections, but this is because facilities without a history of regular FDA inspections are likely to be less familiar with our requirements. It is very important to keep in mind that our requirements for these facilities are designed to prevent problems. If an inspection uncovers an issue at a facility, it does not mean there is a defect with the marketed product. Rather, the inspection is meant to assure that there will *not* be a problem with the quality of a marketed product.”

CDER Office of Compliance **Donald Ashley** added that 80-90% of foreign drug makers that are inspected are substantially compliant with FDA requirements. “When we do identify manufacturing issues, we see similar issues in the United States and around the world,” he said. “Some manufacturers are still working on improving their processes.

Addressing Eban’s criticism in the book about FDA’s practice of announcing an inspection weeks in advance for planning purposes, Kopcha said that the agency does conduct unannounced inspections when necessary. “For example,” he said, “if we receive information from a credible informant or a complaint involving allegations of data destruction or manipulation, or our own reviewers identify concerns, we will conduct an unannounced inspection of the facility to investigate the allegations. If we find problems, regardless of whether the facility is domestic or foreign, we immediately take action to address potentially harmful medicine, such as recommending the company recall its medicine if it is already on the U.S. market. If it is a foreign manufacturer, we may put companies on import alert to block potentially unsafe medicines from entering the U.S. market. Import alerts are one of our most effective tools for preventing substandard medicines from reaching U.S. patients.”