On FDA's Front Lines, Investigators Protect Public
Investigators Protect Public
by Dori Stehlin

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.

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."

Two on a Team

Take Roanoke, Va., for example. That's where MacLaughlin works, along with    
Dennis L. Doupnik. Although both of them have specialties--MacLaughlin's is   
oxygen repackers and Doupnik's is illegal sales of prescription drug          
samples--they are responsible for everything in Southwestern Virginia.

"There's a cosmetics manufacturer down here, an infant formula plant, and     
lots of medical devices," says MacLaughlin.

And sometimes there's a chance to go undercover.

"It's not uncommon for vets to sell prescription animal drugs without         
writing a prescription or ever examining the animal," says Doupnik. "So       
sometimes I'll get an assignment to go and see what I can buy. I must admit,  
I always want the vet to say no."

In addition to covering the Roanoke area, MacLaughlin and Doupnik are         
frequently called on to help out other offices in Virginia. 

In fact, the oxygen repacker MacLaughlin inspected was in Richmond. FDA has   
five investigators in Richmond, but one was preparing for a three-week        
assignment inspecting European drug firms, another was handling seafood       
inspections, and the other three were relatively new and still learning the   
ropes.

MacLaughlin's inspection provided a perfect on-the-job training opportunity   
for new investigator Kathleen Sinninger. A 1989 biology graduate of the       
University of Richmond, she joined FDA in April 1991.

She was on the job eight months before she accompanied MacLaughlin to the     
oxygen repacker. A few weeks after those inspections she started inspecting   
gas repackers by herself.

She admits she was pretty nervous that first time on her own.

"Before I went on the first one, I spent a day going over old [inspection]    
reports and FDA's guidelines," says Sinninger. "I actually spent more time    
preparing [for the inspection] than I spent inspecting."

* * * *


"What if I don't make these changes?" the manager asks as he leans back in    
his office chair and smiles. "Will you do anything?"

MacLaughlin isn't smiling. He explains the several steps of legal action      
open to the agency and adds that, "We will do something."

* * * *


If firms won't cooperate, the first step is usually a warning letter from     
FDA outlining the violations the company needs to correct. Further            
resistance can result in seizures, injunctions and prosecutions.

Part Cop, Part Counselor

The priority for investigators is public safety, and since they are part of   
the public, their own safety is also at stake.

"If I get hit by a car--or, even worse, if my kids get hurt--I want to be     
sure they're testing blood correctly," says blood bank specialist Morrison.

If she finds problems, her goal is to avert disaster. To accomplish that      
goal, she explains, "we have to work with them to make sure problems are      
fixed."

Dori Stehlin is a staff writer for FDA Consumer.
New Unit Fights Crime

Tampering. Counterfeit drugs. Illegal sales of prescription drug samples.     
These activities aren't just violations of FDA regulations. These are         
criminal activities, and identifying and arresting the suspects requires      
special training, skills and equipment.

Although FDA's investigators have always handled criminal investigations      
along with their regular regulatory inspections, criminal activity involving  
FDA-regulated products is increasing, says Ronald Chesemore, FDA's associate  
commissioner for regulatory affairs. In response to the increase, FDA has     
established the Office of Criminal Investigations and is hiring               
investigators, officially called criminal investigators, who will focus       
solely on investigating criminal violations of FDA's laws.

These criminal investigators will have specialized training in criminal       
investigative techniques. Like other federal "special agents" in agencies     
such as the Drug Enforcement Administration, the Customs Service, and the     
FBI, FDA's new agents will be experts in the use of firearms, arrest          
techniques, undercover operations, and constitutional law.

Terrell L. Vermillion, a former special agent with the U.S. Secret Service,   
will supervise the approximately 100 special agents assigned to the new       
criminal investigations office. The agents will be located in OCI field       
offices in New York, Newark, Miami, Kansas City, Chicago, and San Diego. The  
agents and supervisors in these field offices will report directly to OCI     
headquarters. n

--D.S.
Map of Field locations

FDA's six geographic regions and the location of the offices that coordinate  
the agency activities in those regions are shown on this map. The district    
offices within these regions are listed on the right. Home base for FDA's     
investigators is one of these 21 district offices or 130 resident inspection  
posts within these districts.