It got lost in the mail” is an age-old excuse that some people use to deal with bills and other bad news that arrives in their mailbox. But, if the envelope is from the U.S. Food and Drug Administration, it’s not a good idea to play dumb or act indifferent.
No medical device manufacturer wants to get a Form 483 or a Warning Letter from the FDA. However, if it does happen, manufacturers must take every possible step to address the issue.