Subpart M — Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
- §1.600 What definitions apply to this subpart?
- §1.601 Who is subject to this subpart?
- §1.610 Who is eligible to seek recognition?
- §1.611 What legal authority must an accreditation body have to qualify for recognition?
- §1.612 What competency and capacity must an accreditation body have to qualify for recognition?
- §1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition?
- §1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?
- §1.615 What records procedures must an accreditation body have to qualify for recognition?
- §1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
- §1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
- §1.622 How must a recognized accreditation body monitor its own performance?
- §1.623 What reports and notifications must a recognized accreditation body submit to FDA?
- §1.624 How must a recognized accreditation body protect against conflicts of interest?
- §1.625 What records requirements must an accreditation body that has been recognized meet?
- §1.630 How do I apply to FDA for recognition or renewal of recognition?
- §1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
- §1.632 What is the duration of recognition?
- §1.633 How will FDA monitor recognized accreditation bodies?
- §1.634 When will FDA revoke recognition?
- §1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?
- §1.636 How do I request reinstatement of recognition?
- §1.640 Who is eligible to seek accreditation?
- §1.641 What legal authority must a third-party certification body have to qualify for accreditation?
- §1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?
- §1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
- §1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?
- §1.645 What records procedures must a third-party certification body have to qualify for accreditation?
- §1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective?
- §1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
- §1.652 What must an accredited third-party certification body include in food safety audit reports?
- §1.653 What must an accredited third-party certification body do when issuing food or facility certifications?
- §1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
- §1.655 How must an accredited third-party certification body monitor its own performance?
- §1.656 What reports and notifications must an accredited third-party certification body submit?
- §1.657 How must an accredited third-party certification body protect against conflicts of interest?
- §1.658 What records requirements must a third-party certification body that has been accredited meet?
- §1.660 Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?
- §1.661 What is the duration of accreditation by a recognized accreditation body?
- §1.662 How will FDA monitor accredited third-party certification bodies?
- §1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
- §1.664 When would FDA withdraw accreditation?
- §1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
- §1.666 How do I request reaccreditation?
- §1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation?
- §1.671 How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?
- §1.672 What is the duration of direct accreditation?
- §1.680 How and when will FDA monitor eligible entities?
- §1.681 How frequently must eligible entities be recertified?
- §1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
- §1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request?
- §1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
- §1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
- §1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
- §1.695 Are the records obtained by FDA under this subpart subject to public disclosure?
- §1.700 Who is subject to a user fee under this subpart?
- §1.705 What user fees are established under this subpart?
- §1.710 How will FDA notify the public about the fee schedule?
- §1.715 When must a user fee required by this subpart be submitted?
- §1.720 Are user fees under this subpart refundable?
- §1.725 What are the consequences of not paying a user fee under this subpart on time?