45 CFR §101.73

1. (a)At the conclusion of an audit, investigation, or other inquiry, or at any other time, HHS may inform the person in writing of HHS' position regarding that person's non-compliance with the requirements of the DPA and other applicable statutes, this part, or an official action.
2. (b)In cases where HHS determines that failure to comply with the provisions of the DPA and other applicable statutes, this part, or an official action was inadvertent, the person may be informed in writing of the particulars involved and the corrective action to be taken. Failure to take corrective action may then be construed as a willful violation of the DPA and other applicable statutes, this part, or an official action.