FDA's Foreign Inspections Requires Special Management 2015

Overview:
Foreign manufacturers face special difficulties when FDA conducts an inspection. The logistics of scheduling an inspection involve much more than firms realize and involves interaction with other federal agencies. Although foreign manufacturers and U.S. manufacturers must conform to the same manufacturing requirements, there are language barriers.

There may be misunderstandings during an inspection that create needless problems. A foreign firm's response to an inspection plays a critical role in how FDA evaluates the firm, something many foreign firms failure to appreciate. Some foreign firms truly do not understand the devastating consequences to their U.S. market. Foreign firms need to develop a strategy for how they prepare for an inspection, how to conduct an inspection and how to respond to an inspection. A failure in any of these steps may lead to the firm being placed on an Import Alert, which closes the U.S. market until the firm passes an inspection. That process does not happen quickly. For international commerce, that kind of delay translates into a big hit on the balance sheet.