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