Procedures for concluding post-approval compliance reviews.

§ 38.64 Procedures for concluding post-approval compliance reviews. (a) Where, as the result of a post-approval review, the Director has made a finding of noncompliance, the Director must issue a Letter of Findings. This Letter must advise the recipient, in writing, of: (1) The preliminary findings of the review; (2) Where appropriate, the proposed remedial or corrective action to be taken, and the time by which such action should be completed, as provided in § 38.90; (3) Whether it will be necessary for the recipient to enter into a written assurance or Conciliation Agreement, as provided in §§ 38.92 and 38.93; and (4) The opportunity to engage in voluntary compliance negotiations. (b) Where no violation is found, the recipient must be so informed in writing.