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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR1.505]



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 L--Foreign Supplier Verification Programs for Food Importers

Sec. 1.505 What evaluation for foreign supplier approval and verification must I conduct?

(a) Evaluation of a foreign supplier's performance and the risk posed by a food. (1) Except as specified in paragraphs (d) and (e) of this section, in approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you must consider the following:

(i) The hazard analysis of the food conducted in accordance with 1.504, including the nature of the hazard requiring a control.

(ii) The entity or entities that will be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, such as the foreign supplier, the foreign supplier's raw material or other ingredient supplier, or another entity in your supply chain.

(iii) Foreign supplier performance, including:

(A) The foreign supplier's procedures, processes, and practices related to the safety of the food;

(B) Applicable FDA food safety regulations and information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety (or, when applicable, the relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States, and information relevant to the supplier's compliance with those laws and regulations); and

(C) The foreign supplier's food safety history, including available information about results from testing foods for hazards, audit results relating to the safety of the food, and responsiveness of the foreign supplier in correcting problems.

(iv) Any other factors as appropriate and necessary, such as storage and transportation practices.

(2) You must document the evaluation you conduct under paragraph (a)(1) of this section.

(b) Approval of foreign suppliers. You must approve your foreign suppliers on the basis of the evaluation that you conducted under paragraph (a) of this section or that you review and assess under paragraph (d) of this section, and document your approval.

(c) Reevaluation of a foreign supplier's performance and the risk posed by a food. (1) Except as specified in paragraph (d) of this section, you must promptly reevaluate the concerns associated with the factors in paragraph (a)(1) of this section when you become aware of new information about these factors, and the reevaluation must be documented. If you determine that the concerns associated with importing a food from a foreign supplier have changed, you must promptly determine (and document) whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities conducted under 1.506 or 1.511(c) need to be changed.

(2) If at the end of any 3-year period you have not reevaluated the concerns associated with the factors in paragraph (a)(1) of this section in accordance with paragraph (c)(1) of this section, you must reevaluate those concerns and take other appropriate actions, if necessary, in accordance with paragraph (c)(1). You must document your reevaluation and any subsequent actions you take in accordance with paragraph (c)(1).

(d) Review of another entity's evaluation or reevaluation of a foreign supplier's performance and the risk posed by a food. If an entity other than the foreign supplier has, using a qualified individual, performed the evaluation described in paragraph (a) of this section or the reevaluation described in paragraph (c) of this section, you may meet the requirements of the applicable paragraph by reviewing and assessing the evaluation or reevaluation conducted by that entity. You must document your review and assessment, including documenting that the evaluation or reevaluation was conducted by a qualified individual.

(e) Inapplicability to certain circumstances. You are not required to conduct an evaluation under this section or to conduct foreign supplier verification activities under 1.506 if one of the circumstances described in 1.507 applies to your importation of a food and you are in compliance with that section.

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