FDA Inspector: ‘I could tell you stories all day.’
You see the headlines all the time: A recall on over-the-counter medicine. Salmonella-tainted peanut butter sickened hundreds. Spinach caused an e. coli outbreak.
So who’s policing our food and medicine to keep us safe?
In Philadelphia, it’s Karyn Campbell and her team. Campbell is investigations branch director for the Philadelphia District office of the U.S. Food and Drug Administration. For our segment “So, What Do You Do?”, where we pair laypeople with scientists to have down-to earth-conversations about science, the founder of the Public Health Nerd Club, Jennifer Chapman, spoke with Campbell.
The job is huge.
“It’s said that we regulate about 25 cents of every consumer dollar spent, so medical devices, biologics, cosmetics, dietary supplements, tobacco, turtles–small turtles–raw milk,” Campbell said.
Human food, pet food, veterinary drugs and consumer products such as microwaves and televisions, also fall under the FDA’s jurisdiction.
“The concern is that they can transmit salmonella, kids play with turtles, put their hands in their mouth and they can contract salmonellosis,” she said.
FDA inspectors work under the authority of the federal Food, Drug, and Cosmetic Act as well as the Public Health Service Act.
Campbell said she had a defining moment early in her career while visiting a company that made sandwiches for vending machines.
The senior investigator asked her to go into the ladies room and make sure the bathroom was fully stocked with soap, paper towels and a sign that said: “Employees Must Wash Hands Before Returning to Work.”
When Campbell checked, she found there was no sink.
“It went downhill from there,” Campbell said. “We saw widespread rodent infestation,”
When a marshal issued a seizure warrant, the president of the company began yelling at the officers and the inspectors.
“It was a very, very uncomfortable situation, you could see the workers were kind of stunned,” Campbell said. But then one worker came up to Campbell and laid a hand on her arm.
“She said to me, you have a very important job,” Campbell said. “It made me realize this is the career that I wanted, 31 years later I’m still here.”
That experience provided one other turning point for Campbell: She no longer eats sandwiches from vending machines.
“If you ask any FDA investigator who’s been around for awhile, you develop your own kind of phobias about what you’ve seen on inspection,” she said.
Many investigations begin with a tip from the public.
In one case, a physician noticed that several patients were not responding as expected to a prescription medicine. In another case, a parent called in because she thought an infant formula made her baby sick.
“We will go out, we will meet with the consumer, try to get information get the medical records, and kind of trace back where was the formula manufactured, get samples to see if there’s anything wrong with the formula.”
The process can be slow.
Campbell says the investigations bureau doesn’t have the power to immediately shutter a company when inspectors find a problem. The government can seize unsafe products to prevent them from getting to consumers, but a shutdown takes longer.
“The decision does not rest with FDA. We have to go to the U.S. Attorney’s office and the federal courts,” Campbell said. “It could take several months.”
FDA conducts many unannounced spot checks, and having an inspector show up at your business can be unnerving.
“In all my years, I have yet to have anyone tell me: ‘Oh, this is a great time for an FDA inspection,” Campbell said. “But I think most companies kind of understand that it comes along with the cost of doing business,” she said.
“They want us out of there as soon as possible, so generally they are very cooperative in getting us the information and the records that we need to see.”
Would you like to be part of our “So, what do you do?” segment – either as a scientist or an interviewer? Let us know us at email@example.com.