Ninety percent of the prescription drugs consumed in the United States are generics, and the majority of them are produced overseas, mostly in India and China. Let’s say you’re a manufacturer looking to get in on America’s $104 billion generic drug market. You want to make the lowest-cost drugs possible and sell them at the highest possible price. How best to proceed?

To do things right, you’ll need approval from the world’s most feared regulator, the US Food and Drug Administration. But that requires that you comply with so-called current good manufacturing practices, which are complex and costly to implement. Who wants to keep a pristine record of every step in the production process and be ready to submit to detailed inspections and data reviews? Wouldn’t it be better if you were able to look like you were following the regulations while actually subverting them instead?

Katherine Eban is an award-winning investigative journalist and the author of two books about the pharmaceutical industry, Dangerous Doses and Bottle of Lies. Buy now. Harper Collins

FDA inspectors typically show up unannounced at domestic manufacturing plants. But overseas operators often get weeks, or even months, of advance notice. That forewarning has given rise to an intricate web of global deception. Here are some of the more innovative techniques the FDA has run into.

1. Serve Inspectors Contaminated Water

Allegation

In March of 2013, FDA investigators visited a facility in Maharashtra, India, operated by Wockhardt Ltd.

During the inspection, they noticed that an employee seemed to be attempting to smuggle a black bag out of the plant. They chased him down a hallway and saw him hurl the bag into a stairwell. When the inspectors retrieved the bag, they found roughly 75 torn manufacturing records inside.

The records concerned the company’s insulin products. They showed that many of the vials Wockhardt had tested contained black metallic particles—which came from defective sterilizing equipment and were potentially deadly—and had failed visual inspection. As the investigators followed the paper trail, they uncovered a formulation area that Wockhardt hadn’t disclosed to the FDA, where the company was using corroded sterilizing equipment to make both insulin and injectable adenosine, used to treat an irregular heartbeat. (The adenosine was destined for the US market.)

Wockhardt’s plant operators also served them “unsealed water bottles,” the report notes, “and each investigator developed stomach problems during the course of inspection.” The vice president of manufacturing “appeared to be threatening investigators” when they refused to remove a finding from their report. “It is suggested that an inspectional team perform the follow-up inspection with a clear emergency plan in place prior to arrival,” the investigators concluded.

Outcome

Two months after the inspection, the FDA restricted the import of drugs from this plant into the United States. With $100 million in drug sales at stake, Wockhardt’s CEO assured investors then that the company would bring the plant into compliance “in a month, or two months maximum.” Six years later, the restriction remains in place. Wockhardt did not respond to requests for comment.

2. Pretest Your Samples in Secret

Allegation

In January of 2013, FDA investigators visited a facility in West Bengal, India, that manufactured chemotherapy drugs for the German pharmaceutical company Fresenius Kabi Oncology.

At the plant’s quality-control laboratory, an investigator scrutinized the results of high-performance liquid chromatography tests, which measure the impurities in a drug sample and display them as a series of peaks in a record called a chromatogram. Toggling back and forth between computer files, the investigator determined that the official chromatograms were stored in the appropriate folders. But in other folders, marked “MISC” and “DEMO,” he discovered what looked like earlier tests of the same drug samples, some a day apart, some a month apart. Not all of the plant’s files moreover, were stored on its main server.