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Patricia O'Connell
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Sonali Gunawardhana Discusses Rise in FDA Warning Letters to Foreign Companies

The Silver Sheet
March 20, 2014

Sonali P. Gunawardhana, of counsel in Wiley Rein’s Food & Drug Law Practice, was quoted in an article published in The Silver Sheet March 19 on the increased number of warning letters issued by the Food and Drug Administration (FDA) to overseas companies.

According to the article, the FDA issued more warning letters to foreign medical device manufacturers in 2013 than it did to domestic manufacturers the same year.  Once a manufacturer takes corrective action and it is evaluated by the FDA, the agency may issue a close-out letter.

Noting that it’s difficult for manufacturers to “sit on pins and needles waiting to see whether the agency thinks things are OK or not,” Ms. Gunawardhana said close-out letters “help the warning letter process come full circle.”  She added that the close-out letters “keep communication lines open between industry and the agency.  It’s accountability.  That’s good.”

If a warning letter is linked to quality, the FDA usually does a second inspection before issuing a close-out letter.  Last year, the FDA issued 56 close-out letters, compared to 62 in 2012.  “Close-out letters are based on the results of a second inspection,” Ms. Gunawardhana said.  “FDA will weigh your response and any other information you submitted to the agency between the time of the first inspection and the second one.  If your second inspection goes well, then you’re going to get the close-out letter.  If you second inspection doesn’t go well, you’re probably going to get some other type of regulatory correspondence.”