Subpart R — Laboratory Accreditation for Analyses of Foods

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• §1.1101 What documents are incorporated by reference in this subpart
• §1.1102 What definitions apply to this subpart?
• §1.1103 Who is subject to this subpart?
• §1.1107 When must food testing be conducted under this subpart?
• §1.1108 When and how will FDA issue a directed food laboratory order?
• §1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
• §1.1110 What are the general requirements for submitting information to FDA under this subpart?
• §1.1113 What are the eligibility requirements for a recognized accreditation body?
• §1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?
• §1.1115 How will FDA evaluate applications for recognition and renewal of recognition?
• §1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
• §1.1117 How may an accreditation body request reinstatement of recognition?
• §1.1119 What are the conflict of interest requirements for a recognized accreditation body?
• §1.1120 How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
• §1.1121 When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
• §1.1122 What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
• §1.1123 What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
• §1.1124 What are the records requirements for a recognized accreditation body?
• §1.1125 What are the internal audit requirements for a recognized accreditation body?
• §1.1130 How will FDA oversee recognized accreditation bodies?
• §1.1131 When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
• §1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?
• §1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
• §1.1140 What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
• §1.1141 What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
• §1.1142 How does a laboratory request reinstatement of LAAF-accreditation?
• §1.1147 What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
• §1.1149 What oversight standards apply to sampling?
• §1.1150 What are the requirements for analysis of samples by a LAAF-accredited laboratory?
• §1.1151 What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
• §1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
• §1.1153 What are the requirements for submitting abridged analytical reports?
• §1.1154 What other records requirements must a LAAF-accredited laboratory meet?
• §1.1159 How will FDA oversee LAAF-accredited laboratories?
• §1.1160 How will FDA review test results and analytical reports?
• §1.1161 When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
• §1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
• §1.1171 How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
• §1.1173 How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?
• §1.1174 How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
• §1.1199 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
• §1.1200 Are the records obtained by FDA under this subpart subject to public disclosure?