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Title 21

This content is from the eCFR and is authoritative but unofficial.

Displaying title 21, up to date as of 9/14/2026. Title 21 was last amended 9/11/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter A —General
  4. Part 1 —General Enforcement Regulations
  5. Subpart R —Laboratory Accreditation for Analyses of Foods
  6. FDA Oversight of LAAF-Accredited Laboratories
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FDA Oversight of LAAF-Accredited Laboratories

§ 1.1159 How will FDA oversee LAAF-accredited laboratories?

(a) FDA may review the performance of LAAF-accredited laboratories at any time to determine whether the LAAF-accredited laboratory continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the LAAF-accredited laboratory that, if not corrected, would warrant corrective action, probation, or disqualification under § 1.1161.

(b) In evaluating the performance of a LAAF-accredited laboratory, FDA may review any of the following:

(1) Records the LAAF-accredited laboratory is required to maintain under this subpart;

(2) Records the recognized accreditation body that LAAF-accredited the laboratory is required to maintain under this subpart;

(3) Information obtained by FDA during a review of the LAAF-accredited laboratory conducted pursuant to paragraph (c) of this section;

(4) Information obtained by FDA during an evaluation of the recognized accreditation body that LAAF-accredits the laboratory;

(5) Analytical reports and test results submitted to FDA; and

(6) Any other information obtained by FDA, including during FDA's inspections or investigations of one or more owners or consignees.

(c) FDA may conduct an onsite review of a LAAF-accredited laboratory at any reasonable time, with or without a recognized accreditation body (or its officers, employees, and other agents) present, to review the performance of a LAAF-accredited laboratory under this subpart. Certain review activities may be conducted remotely if it will not aid in the review to conduct them onsite.

(d) FDA may report any observations and deficiencies identified during its review of LAAF-accredited laboratory performance under this subpart to the recognized accreditation body.

§ 1.1160 How will FDA review test results and analytical reports?

(a) If FDA finds that any test result, analytical report, related documents, or the associated analysis contains deficiencies or otherwise indicates that any aspect of the food testing is not being conducted in compliance with this subpart, FDA will notify the LAAF-accredited laboratory that submitted the analytical report of any deficiency and may:

(1) Require the laboratory to correct the test result, analytical report, related documents, or the associated analysis;

(2) Revoke permission to submit abridged reports for that major food testing discipline under § 1.1153(b);

(3) Require a corrective action under § 1.1161(a);

(4) Consider the analysis to be invalid; and/or

(5) Notify the owner or consignee of the deficiency.

(b) FDA may report any deficiencies identified during its review of any test results, reports, and related documents under this subpart to the recognized accreditation body that LAAF-accredits the laboratory.

(c) Nothing in this subpart shall be construed to limit the ability of FDA to review and act on information received about food testing, including determining the sufficiency of such information and testing.

§ 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?

(a) Corrective action. FDA may require corrective action to address any deficiencies identified while reviewing a LAAF-accredited laboratory's performance under this subpart.

(1) FDA will notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to FDA for approval.

(2) The LAAF-accredited laboratory must handle FDA's notification as a complaint under ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.9, implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit both the results of the complaint investigation and subsequent corrective action to FDA.

(3) FDA will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.

(b) Probation. If FDA determines that a LAAF-accredited laboratory has not effectively implemented corrective action or otherwise fails to address deficiencies identified, FDA may put the LAAF-accredited laboratory on probation for one or more methods and require corrective action under paragraph (a) of this section.

(1) FDA will notify the LAAF-accredited laboratory and its recognized accreditation body of the grounds for the probation, the method(s) covered by the probation, and all deficiencies requiring corrective action via the process described in paragraph (a) of this section.

(2) FDA will provide notice of a LAAF-accredited laboratory's probation on the website described in § 1.1109.

(3) FDA will review the corrective action and will notify the LAAF-accredited laboratory and its recognized accreditation body whether the corrective action is acceptable.

(4) A LAAF-accredited laboratory will remain on probation until the LAAF-accredited laboratory demonstrates to FDA's satisfaction that it has successfully implemented appropriate corrective action.

(5) If FDA determines that a LAAF-accredited laboratory on probation has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, FDA may disqualify the LAAF-accredited laboratory under paragraph (c) of this section.

(c) Disqualification. FDA may disqualify a LAAF-accredited laboratory from submitting analytical reports under this subpart for one or more methods for good cause, which may include any of the following reasons:

(1) Deliberate falsification of analytical reports, testing results, or other records submitted to FDA.

(2) Failure of a LAAF-accredited laboratory on probation to effectively implement corrective action or otherwise address identified deficiencies.

(3) Other failure to substantially comply with this subpart where the laboratory's recognized accreditation body has not reduced the scope of or withdrawn LAAF-accreditation of the laboratory.

(d) Disqualification procedures.

(1) FDA will issue a notice of disqualification to a LAAF-accredited laboratory and its recognized accreditation body, which will include:

(i) The grounds for disqualification;

(ii) The method or methods to which the disqualification applies;

(iii) The date the disqualification will be effective;

(iv) The procedures for requesting a regulatory hearing on the disqualification under § 1.1173; and

(v) The procedures for requesting reinstatement after disqualification under § 1.1142.

(2) FDA will provide notice of a LAAF-accredited laboratory's disqualification on the website described in § 1.1109.

§ 1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?

(a) A LAAF-accredited laboratory that FDA has put on probation for one or more methods is permitted to continue to conduct food testing under this subpart; however, a LAAF-accredited laboratory that is on probation for one or more methods is not permitted to submit abridged analytical reports for the major food testing discipline of which the probationary methods are part.

(b) If FDA disqualifies a LAAF-accredited laboratory for all methods within its scope of LAAF-accreditation, the laboratory is immediately ineligible to conduct food testing under this subpart. If FDA disqualifies a LAAF-accredited laboratory for specific methods within the scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods for which the laboratory has been disqualified to conduct food testing under this subpart.

(c) With respect to food testing conducted by the laboratory prior to its disqualification, FDA may refuse to consider results and associated reports of food testing conducted under this subpart if the basis for the disqualification of the laboratory indicates that the specific food testing conducted by the laboratory may not be reliable.

(d) Within 10 business days of the date of issuance of disqualification, the laboratory must provide the name and email address of the custodian who will maintain and make available to FDA the records required by § 1.1154, and the street address where the records will be located.

(e) Within 10 business days of the date of issuance of a notice of probation or disqualification, the laboratory must notify any owners or consignees for which it is conducting food testing using methods for which it is being placed on probation or disqualified under this subpart, that it is on probation or has been disqualified.

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