On FDA's Front Lines : Trust and Verify, Making the Grade

by Food and Drug Administration (FDA)

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Trust and Verify

When MacLaughlin inspects a gas repacker, he asks so many questions it might sound like he knows almost nothing about this kind of operation. His apparent ignorance, however, is simply an investigative technique.

"I ask them questions to see if they know the answers," he says.

"Our job is to keep [industry] honest," says Troy Williams, an investigator in FDA's Richmond, Va., office. "I will trust, but I'll also make them prove themselves."

How do investigators get this proof? First they observe actual manufacturing practices to see if the process is being done correctly and according to the company's and FDA's manufacturing standards. Then they review manufacturing records to make sure every step required to produce the product according to the regulations is being taken.

For example, filling cylinders with oxygen for medical use requires several steps and lots of records to make sure nothing gets out of control. If the cylinder is filled with the wrong gas — 100 percent carbon dioxide, for example — it can cause brain damage and even death within minutes, says MacLaughlin. "Without documents, whatever they tell me is just rumor."

Inspecting gas repackers, as well as establishments such as drug and medical device manufacturers, blood banks, and low-acid canned food manufacturers, requires a great deal of technical expertise. For example, blood bank inspections require knowledge of the testing techniques required to screen blood for infections and the proper procedures to ensure quality samples. But that's not all.

"We're very much like computer systems analysts in blood banks today," says Morrison. She explains that today's blood banks rely heavily on computers to track the test results and destinations of the donated blood. If the software can't keep up with the test results, she says, there could be trouble.

And then, there're always a few filthy food warehouses to inspect. Investigators are on the lookout for conditions such as holes in walls or ceilings or overflowing garbage in food processing areas that would allow rodents, birds and insects to contaminate the food.

Making the Grade

"There's no college in the country that trains people to work for us," says Robert C. Fish, director of FDA's division of field investigations. "We have to make that person an investigator."

However, college — specifically a bachelor's degree that includes 30 hours of science — is a prerequisite for getting a job as an investigator.

Once hired, basic training for new investigators takes about six months and combines classroom and on-the-job experience.

The first three months' classes include basics of sample collection, evidence development, photography, and how to interview and interrogate.

Between classes, the new investigators tag along with more experienced colleagues. Basic tasks — sample collections, interviewing consumers — may require only one or two training inspections before new investigators can handle them independently.

In the second three months, classes cover inspections of specialized industries, including:

• sterile drugs
• blood banks
• medical devices
• oxygen repackers
• low-acid canned foods

By the time the one-year mark rolls around, a new investigator may have taken as many as 20 classes. In addition, in some of the bigger offices, he or she may also have started to focus on a specialty such as medical devices, blood banks, or sterile drugs.

As manufacturing becomes more complex and FDA's responsibilities expand in areas such as biotechnology and seafood, investigators need more specialized training.

But, "for the average investigator, specializing is a luxury," says Fish. "Especially in some of the smaller offices, investigators have to be able to handle everything."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.