Table of Contents
The High Stakes of FDA Approved Imports
Much has changed since 1907 when Theodore Roosevelt appointed the FDA’s first commissioner, Harvey Washington Wiley, M.D.
The size and scope of the Food and Drug Administration’s oversight are easily understated. Beyond regulating 75% of the USA’s native food supplies, the FDA also regulates imported goods.
- 35% of medical devices used in this country are imports.
- 64% of biologics sales are imports.
- 53% of fresh fruit, 29 percent of vegetables
- 93% of seafood consumption by volume are imports.
- 4% of animal product sales are imports
“All FDA-regulated products imported into the United States are required to meet the same laws and regulations as domestic goods. Imported foods must be pure, wholesome, safe to eat and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe for their intended use and properly labeled; radiation-emitting devices must meet established standards; tobacco products must meet U.S. requirements, and all products must contain informative and truthful labeling in English.” – FDA
The "Whole-Listic" Guide to FDA Inspections
Based on message receipts from internal FDA communications, readers get a glimpse into the high stakes, bizarre, heroic, tragic, and even comical ways that overseas drug manufacturers dupe the FDA (or at least attempt to).
The excerpts below, originally published by Wired magazine’s Katherine Eban, show just how far foreign manufacturers go to deceive inspectors in attempt to win over lucrative market shares. Otherwise, these products would not meet FDA standards or Good Manufacturing Practices (GMP).
Whole-Listic: A Whole-List of Things Not to Do
The 6 Step Guide to FDA Inspection Failure
(1) Smuggle Evidence, Serve Inspectors Contaminated Water
Smuggle Evidence
During the inspection, [FDA inspectors] 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.
Use Corroded Sterilization Equipment for Injectables
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.)
Serve Contaminated Water
Wockhardt’s plant operators also served them “unsealed water bottles,” the report notes, “and each investigator developed stomach problems during the course of inspection.”
Forget the FDA often Arrives Unannounced
Although Ranbaxy expected the inspection on a Monday, the investigators arrived unannounced the day before. According to the FDA’s inspection report, in the quality-control laboratory, they found dozens of workers hunched over documents and backdating them.
Make Incriminating Evidence Visible, Lots of It
On one desk, they found a notebook that appeared to list all the records the employees planned to falsify. There were Post-It notes stuck to numerous surfaces, apparently noting what data to change—employee trainings, laboratory analyses, cleaning records.
(2) Lose the Key to Your Own Door, Break It Down
"During the inspection, an investigator claims to have found a filthy, small, locked laboratory, its entrance partially blocked by a piece of bulky equipment. Plant officials claimed that the laboratory had been decommissioned some six years earlier. But the FDA investigator demanded it be opened.
After a lengthy and unsuccessful effort to find the key, the firm’s president broke in the door.
"Inside, the investigator found a computer running tests on ingredients for cephalosporin, an oral antibiotic used to treat bacterial infections. Some of those test results were not entered into the plant’s official data system, which, the inspectors wrote, was “necessary to assure compliance.”
(3) Don't Like Your Research Data? Write Your Own
In the plant’s computer systems, investigators discovered even more consequential falsifications. The FDA requires plants to investigate failing, or “out-of-specification,” test results. But in the gas chromatography laboratory, technicians were retesting failing drug samples and “over-writing raw data files ... until acceptable results are achieved,” according to the investigators’ account.
(4) Fake it Til' You Make It
As a manufacturer of sterile drugs—including injectable forms of the antibiotics cephalosporin and meropenem—the plant was required to test its environment, including its air, water, and surfaces, to ensure they were free of microbial contamination.
Investigators reported that the testing data appeared to be in perfect order; data worksheets in the microbiology laboratory showed that samples had been prepared, incubated, and examined.
But the samples weren’t presented to the investigators. As an FDA inspection report noted, “According to the QC Microbiologist, these samples were never prepared/incubated, and the documentation had been falsified.” Much of the laboratory, it seemed, was fake.
(5) When in Doubt, Run
On the third day of the inspection, as the investigator was returning from a lunch break, he saw an analyst quickly remove a thumb drive from one of the chromatography machines and slip it into his lab coat.
The investigator asked that he hand over the thumb drive, but the man“began running and fled the laboratory premises,” according to the inspection report.Fifteen minutes later, a manager returned to offer him the thumb drive, but the investigator had no idea whether it was the same one. He noted the incident—a refusal to share records—as import-ending conduct.
(6) If You Cant Run, Take the Investigator Hostage
“According to internal emails reviewed by WIRED, soon after the investigator and her translator began their work, worried company officials started interrogating them and questioning their authority to inspect.
After the firm’s general manager became visibly upset, the inspectors went to gather their things in the conference room.
The GM refused to let them leave, effectively imprisoning them, and called the police, who, according to the FDA, claimed their credentials were fake.
More than an hour later, after the intercession of Chinese drug regulators, the FDA employees were finally freed.
However, the agency declined to classify the incident as refusing an inspection—grounds for an automatic import ban—because it wasn’t clear whether the plant manager who’d imprisoned the investigators “was making a specified refusal,” one senior FDA official noted.”
