The FDA is stepping in to suspend the use of a cultured skin substitute developed at the Shriners Burn Hospital in Cincinatti because of a previous inspection report that itemized hundreds of violations in the product's clinical research study. Prior to the FDA's warning letter, the same study had received a warning letter from the Office of Human Research Protection (OHRP) due to wrong informed consent. The OHRP required the doctors audit the patient files to make sure that the correct forms were being used but the FDA found the same violations in their inspection that led to the warning letter and subsequent denial of this particular burn treatment.