§1.1125. What are the internal audit requirements for a recognized accreditation body? — Inbound Citations

(b) A recognized accreditation body must submit to FDA a report of the results of the internal audit conducted pursuant to § 1.1125 within 45 calendar days of completing the audit. The audit report must include:

(1) A description of the internal audit conducted;

(2) A description of any identified deficiencies;

(3) A description of any corrective action taken or planned, including the timeline for such corrective action; and

(4) A statement disclosing the extent to which the internal audit was conducted by personnel different from those who perform the activity or activities that were audited.