FDA Facility Inspections for Offshore Drug and Medical Device Manufacturing: Two Different Strategies

Earlier this year, MDCI posted a blog entry about the FDA’s plan to increase the number of employees “on the ground” in regions of the world known to be hotbeds for medical device manufacturing. The reasoning behind this personnel decision is to improve the frequency of foreign facility inspections. By expanding its inspection team through the establishment of in-country offices staffed by federal employees, the FDA intends to expand both the scope and quality of its medical device manufacturing facility inspections.

A recent report by Bloomberg, however, seems to at least in part contradict this FDA inspection strategy. An article published by BusinessWeek.com in the first week of February stated that the FDA will in fact  be looking to expand the role of its third-party inspection teams when it comes to handling the regulatory compliance of facilities located outside of the United States.

Specifically, the report referred to drug manufacturing facilities, but it is unusual to note the apparent divergent strategies being employed by the FDA in terms of how it handles drug inspections versus medical device inspections. The simplest explanation as to why the Administration would enhance third-party inspections on the one hand while ramping up federal employee inspections on the other could come down to volume. According to the Bloomberg article, foreign drug manufacturing facilities are inspected, on average, only once every nine years. With the proliferation of offshore drug manufacturers outstripping those of medical device manufacturers, the engagement of contract facilities inspectors could be the FDA’s only viable method for keeping up with the growing regulatory environment.

At MDCI, we recommend that medical device companies who have chosen to embrace offshore manufacturing as a way of managing costs stay abreast of any changes made by the FDA in its inspections policies. However, the FDA adopts different approaches to the inspection of foreign medical device manufacturing facilities, drug manufacturing facilities, and even clinical test sites located outside of the United States. It is important to be able to separate the different regulatory spheres juggled by the Administration and not assume that policies implemented in one sector will necessarily affect those of another.

Benjamin Hunting
MDCI Blogging Team

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