On FDA's Front Lines: Investigators Protect Public

by Food and Drug Administration (FDA)

The manager of the oxygen repacking firm was getting a bit testy. He thought his production records were just fine, but the FDA investigator said the records were incomplete.

"You guys have been in here four times and no one has ever told me that before," the manager said.

Investigator James C. MacLaughlin apologized for perceived past oversights and then cited the regulation, sub-part and verse, with the same assurance — and accuracy — that other people rattle off their addresses or Social Security numbers.

"Is that written somewhere?" the manager asked. "I'd like to see it."

No problem. MacLaughlin pulled his copy of the Code of Federal Regulations out of his briefcase and flipped it open to the appropriate page.

Does MacLaughlin — and, for that matter, do all FDA investigators — have all the citations for FDA regulations memorized?

"I cheated," MacLaughlin later confessed. "I basically knew which regs would apply to this inspection, but I reviewed them all this morning."

To make sure that the "regs" — there are nine volumes of regulations that specifically apply to FDA — are being followed, approximately 1,000 men and women inspect the drug manufacturers, blood banks, food manufacturers and warehouses, medical device manufacturers, and a myriad of other establishments in this country involved with FDA-regulated products. They are FDA's investigators, and if your product falls under the agency's purview, they'll be by to visit.

There are more than 90,000 establishments in the United States that FDA investigators must inspect. In addition, investigators handle special assignments, such as responding to consumer complaints of defective or tainted products, and making sure recalled products are pulled from retailers' shelves.

Shifting Priorities

Decisions on what to inspect and when are based on several factors. FDA's headquarters prepares nationwide annual work plans that cover all the basic inspection responsibilities. Those work plans are refined, usually bimonthly, in each district office to meet the specific inspection needs of that area.

In addition, there are special assignments from the different FDA centers, which oversee foods and cosmetics, drugs, biologics, medical devices, and electronic products that emit radiation. For example, in 1991, FDA initiated a special program to inspect all seafood processors and repackers — 3,852 plants nationwide — for compliance with sanitation, food handling, and other good manufacturing practices.

Of course, emergencies — recalls of defective products, tampering incidents, natural disasters — require, and get, immediate attention.

"The hardest thing about doing this job is that priorities are constantly shifting," says Stan Woollen, supervisor of the Arlington, Va., resident post. And there's nothing like a consumer complaint to change plans, he adds.

A consumer complaint threw FDA investigator Ellen Morrison's carefully planned blood bank agenda off schedule right before Thanksgiving 1991. Morrison, who works with Woollen in the Arlington office, had to respond when a consumer called to complain that a bottle of cola had a funny smell and burned her mouth when she took a drink.

"I had to go out to the bottling plant and see if I could pinpoint the problem," says Morrison, a blood bank specialist. "I hadn't been in a food plant in years."

But she hadn't forgotten the basics of a food plant inspection she had learned when first trained by FDA, including a critical skill for all investigators — diplomacy.

FDA does not have the authority to demand a recall of a food product. If a product is a risk to the public health and the manufacturer refuses to recall the product voluntarily, the agency's legal recourse is to pursue seizure and injunction through the Department of Justice and the federal courts.

But when Morrison arrived at the bottling plant, all she knew was that one consumer had reported a possible injury and that FDA's Baltimore lab had found an "off" odor. It wasn't enough for legal action, but it was enough to cause concern, so she was hoping a little diplomacy would lead to a little voluntary action.

However, it was the day before Thanksgiving, Morrison explains, and the last thing the manager of the bottling plant wanted to do was send his sales representatives out to the stores. Of course, "he didn't want to even hear the word 'recall'," she says. "It was a real challenge, but I finally convinced him it was the right thing to do."

The manager agreed to pull all of the soda with the suspect lot number off the shelves of the retail stores to which it had been distributed. Morrison's inspection of the bottling plant didn't uncover any problems, and final lab tests didn't reveal any apparent contaminants. No other injuries were reported.

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.