Top five tips for successfully addressing warning letters
Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business both culturally and financially. But getting to that point may be a slippery slope if the issues in the letter are not addressed effectively and expediently.