FDA Inspections May Lose Their Element of Surprise

Hey there, trick-or-treaters!

Wanna spook that guy down the street who owns the medical device company?

When he opens the door, yell, “Surprise! It’s the FDA!”

Fortunately for him, though, those surprise factory visits from Food and Drug Administration inspectors searching for violations of manufacturing standards, record-keeping rules and the like may become a thing of the past.

The agency’s Los Angeles district, which is based in Irvine, is the FDA’s busiest participant in an experimental national program to give device makers advance notice of inspections. The district, which includes Arizona and nine counties in Southern California, regulates 3,790 medical device makers, far more than any other district.

Its inspectors made 78 pre-announced inspections of device makers in the first five months of the new program, which started last April. Companies are notified five days in advance, then have an opportunity to postpone the inspection as much as five more days.

Elaine Messa, the district’s director, says it’s unlikely that the advance warning would give violators a chance to cover their tracks because so much of what the agency looks for involves items that are hard to fudge, such as long-term record keeping. She says that inspectors issued warning letters to 12% of the companies they visited under the new program, roughly the same percentage as for surprise visits in the past.

The experimental effort was launched after the industry complained of hassles involved in assembling personnel and data on a moment’s notice. But the FDA also sees some benefits from the experiment. “We’ve found that our inspections are more efficient, that industry has the people and the documents ready,” Messa says.

Next year, the agency is expected to consider adopting prearranged inspections as routine procedure. However, companies that have recently received warning letters probably would remain subject to surprise inspections.

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Barbara Marsh covers health care for The Times. She can be reached at (714) 966-7762 and at barbara.marsh@latimes.com.