CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR1.1160]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart R - Laboratory Accreditation for Analyses of Foods

FDA Oversight of LAAF-Accredited Laboratories

Sec. 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.