Originally Published MDDI January 2003

NEWSTRENDS

Maureen Kingsley

By many accounts, the current FDA inspection techniques are fair. But are they flawless? "In terms of QSIT's effect on the industry, I think it's been positive," says Steve Lawrence, a partner with Hogan & Hartson LLP (Washington, DC) in the firm's Irvine, California, location.

Although the current QSIT is only about two years old, its recent history traces back to 1996, when Section 830 of the Code of Federal Regulations 21 was reorganized. QSIT development played a major part in that overhaul. At the time, FDA's goals for its inspections of medical device facilities were to decrease inspection time, increase focus, and ensure quality system regulation coverage. A study and validation of QSIT conducted in 1998 in three major cities showed that QSIT did, in fact, provide a well-defined, succinct, and prescriptive methodology for inspection. Lawrence believes the experience companies have had with QSIT thus far "has been very thorough and fair. They know the rules, the rules are published."

In 2001, FDA determined that additional action was required to raise the number of inspections performed each year. Across the country, medical manufacturing coverage was badly backlogged, and resources dwindled, according to James Beaulieu, a Minneapolis-area investigator. In response, FDA implemented a new strategy to shorten inspections. The traditional baseline inspection was renamed Level 2, and the CAPA +1 inspection was created as a new, less-comprehensive (but presumably effective) process.

As of the new fiscal year beginning in October 2002, about 60% of inspections were CAPA +1, Beaulieu said during the MD&M Minneapolis conference this past autumn. This statistic suggests that the agency views the CAPA +1 inspections as successful and valuable. "I think [QSIT-type inspections] are the wave of the future," Lawrence says. As evidence, he points to the changes being made in the way manufacturers of pharmaceuticals are inspected. "There's a pilot program that tries to make the drug inspections more like the QSIT inspections," he says. "That's an indication that FDA thinks this approach is working and wants to apply it to other places."

Not all inspections are abbreviated, however, and QSIT isn't devoid of problems. There are still inspections of medical device facilities that take several weeks to complete and which involve several inspectors. "That's an area of great controversy," says Larry Pilot, partner at McKenna & Long (Washington, DC) and a former FDA employee familiar with inspections. "The inspection that is lengthy and sometimes involves multiple investigators, for which the burden on the manufacturer is great, and for which the time invested by FDA through its inspectors, is expected to produce some kind of a result." He cites a big-name example: "Look at Abbott Laboratories for a model of this. I'm sure they're not happy to be this model."

It surprises Pilot that large, well-known companies, which are expected to be more savvy than their smaller counterparts, have become "victims of the inspectional process." He attributes this to a mindset by some in the agency of, "We're going to get them."

To offset this bias, Pilot sets forth some concrete suggestions. "Properly manage your inspection. Take measures to ensure that those who manage the inspections are competent," he says. "Take advantage of the opportunity to dialogue with inspectors. That dialogue can be as short as 10 minutes, or as long as it takes to go through page after page of observations." Pilot also advises those being inspected to take advantage of the post-inspection management conference. "Companies can control their destinies," he says.

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