International manufacturers subject to FDA oversight can expect, sooner or later, to be notified of an upcoming inspection at their facility.
After this initial notice, many companies have a few questions about what, if anything, they can expect to receive from FDA before investigators show up at the door.
The FDA follows general standard operating procedures for conducting foreign inspections and most who have experienced this themselves tend to agree that investigators typically adhere closely to them barring outstanding circumstances.
Before going any further, however, it's important to note that if FDA is planning to conduct an inspection because of a credible threat to public health in the United States, investigators may arrive unannounced. These could be characterized as "directed" or "for cause" inspections rather than a "routine" inspection.
While FDA does not currently have statutory authority authorizing inspections of international establishments, the agency does have mechanisms to assure compliance by foreign firms.
With this important distinction in mind, we've summarized the important points international firms need to know when preparing for a routine foreign FDA inspection below.
• Investigators are instructed to identify specific targeted dates for conducting the inspection that are mutually agreeable to both the firm and the FDA.
• These targeted dates are subject to negotiation in order to reach a mutual agreement between both parties.
• International inspections are pre-announced to account for a number of factors, including:
• Possibly sensitive political situations
• Local holidays and other international scheduling complications
• Preventing scheduling during a time when the firm is not in operation or otherwise not in a state primed for inspection
• To ensure the availability of English-speaking personnel
• International firms should expect FDA investigators to issue a request containing the proposed inspection dates either through direct contact or through the firm's U.S. agent.
• Investigators will likely identify the product(s) to be inspected prior to arrival.
Read our other articles to learn more about preparing for the FDA inspection itself:
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