A routine inspection of test site (Advanced Interventional Pain Center, Indiana) was conducted in September of 2013, where the LILA medical device was used for a clinical trial. The inspection identified 9 patients who were not part of the trial, but were misconstrued as being part of the trial. The inspectors requested the required additional documentation to be sent to FDA’s Detroit Office. In response, the IRB was disbanded, since the clinical trial was already completed and new patients were not being enrolled while the additional documents were sent to FDA’s Detroit office. The additional documentation when sent to FDA’s Detroit office were returned as undeliverable several times. See pictures below. The non receipt of the additional documentation triggered the FDA warning letter from its DC office. On clarification, FDA issued a final letter in May of 2014 indicating the actions taken were satisfactory, eventually resolving the matter (See attached). This final letter is not available on FDA’s website for public view resulting in incomplete and incorrect information regarding these warnings by the public who happen to see only the warnings but not response or the resolutions. For these reasons, C Laser Inc is posting this information for public view and clarification. Despite requests to the FDA to retract its unnecessary, not at fault warning letters, FDA has not done so. From the evidence presented below, it is clear that the FDA warning letters were the result of FDA’s own non compliance in having FDA offices with undeliverable addresses and not the test site or the investigator’s fault.