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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 2018.

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 2]
[Revised as of April 1, 2018]
[CITE: 21CFR117.475]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

Subpart G--Supply-Chain Program

Sec. 117.475 Records documenting the supply-chain program.

(a) The records documenting the supply-chain program are subject to the requirements of subpart F of this part.

(b) The receiving facility must review the records listed in paragraph (c) of this section in accordance with 117.165(a)(4).

(c) The receiving facility must document the following in records as applicable to its supply-chain program:

(1) The written supply-chain program;

(2) Documentation that a receiving facility that is an importer is in compliance with the foreign supplier verification program requirements under part 1, subpart L of this chapter, including documentation of verification activities conducted under 1.506(e) of this chapter;

(3) Documentation of the approval of a supplier;

(4) Written procedures for receiving raw materials and other ingredients;

(5) Documentation demonstrating use of the written procedures for receiving raw materials and other ingredients;

(6) Documentation of the determination of the appropriate supplier verification activities for raw materials and other ingredients;

(7) Documentation of the conduct of an onsite audit. This documentation must include:

(i) The name of the supplier subject to the onsite audit;

(ii) Documentation of audit procedures;

(iii) The dates the audit was conducted;

(iv) The conclusions of the audit;

(v) Corrective actions taken in response to significant deficiencies identified during the audit; and

(vi) Documentation that the audit was conducted by a qualified auditor;

(8) Documentation of sampling and testing conducted as a supplier verification activity. This documentation must include:

(i) Identification of the raw material or other ingredient tested (including lot number, as appropriate) and the number of samples tested;

(ii) Identification of the test(s) conducted, including the analytical method(s) used;

(iii) The date(s) on which the test(s) were conducted and the date of the report;

(iv) The results of the testing;

(v) Corrective actions taken in response to detection of hazards; and

(vi) Information identifying the laboratory conducting the testing;

(9) Documentation of the review of the supplier's relevant food safety records. This documentation must include:

(i) The name of the supplier whose records were reviewed;

(ii) The date(s) of review;

(iii) The general nature of the records reviewed;

(iv) The conclusions of the review; and

(v) Corrective actions taken in response to significant deficiencies identified during the review;

(10) Documentation of other appropriate supplier verification activities based on the supplier performance and the risk associated with the raw material or other ingredient;

(11) Documentation of any determination that verification activities other than an onsite audit, and/or less frequent onsite auditing of a supplier, provide adequate assurance that the hazards are controlled when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans;

(12) The following documentation of an alternative verification activity for a supplier that is a qualified facility:

(i) The written assurance that the supplier is a qualified facility as defined by 117.3, before approving the supplier and on an annual basis thereafter; and

(ii) The written assurance that the supplier is producing the raw material or other ingredient in compliance with applicable FDA food safety regulations (or, when applicable, relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States);

(13) The following documentation of an alternative verification activity for a supplier that is a farm that supplies a raw material or other ingredient and is not a covered farm under part 112 of this chapter:

(i) The written assurance that supplier is not a covered farm under part 112 of this chapter in accordance with 112.4(a), or in accordance with 112.4(b) and 112.5, before approving the supplier and on an annual basis thereafter; and

(ii) The written assurance that the farm acknowledges that its food is subject to section 402 of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States);

(14) The following documentation of an alternative verification activity for a supplier that is a shell egg producer that is not subject to the requirements established in part 118 of this chapter because it has less than 3,000 laying hens:

(i) The written assurance that the shell eggs provided by the supplier are not subject to part 118 of this chapter because the supplier has less than 3,000 laying hens, before approving the supplier and on an annual basis thereafter; and

(ii) The written assurance that the shell egg producer acknowledges that its food is subject to section 402 of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws and regulations of a country whose safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States);

(15) The written results of an appropriate inspection of the supplier for compliance with applicable FDA food safety regulations by FDA, by representatives of other Federal Agencies (such as the United States Department of Agriculture), or by representatives from State, local, tribal, or territorial agencies, or the food safety authority of another country when the results of such an inspection is substituted for an onsite audit;

(16) Documentation of actions taken with respect to supplier non-conformance;

(17) Documentation of verification of a supply-chain-applied control applied by an entity other than the receiving facility's supplier; and

(18) When applicable, documentation of the receiving facility's review and assessment of:

(i) Applicable documentation from an entity other than the receiving facility that written procedures for receiving raw materials and other ingredients are being followed;

(ii) Applicable documentation, from an entity other than the receiving facility, of the determination of the appropriate supplier verification activities for raw materials and other ingredients;

(iii) Applicable documentation, from an entity other than the receiving facility, of conducting the appropriate supplier verification activities for raw materials and other ingredients;

(iv) Applicable documentation, from its supplier, of:

(A) The results of sampling and testing conducted by the supplier; or

(B) The results of an audit conducted by a third-party qualified auditor in accordance with 117.430(f) and 117.435; and

(v) Applicable documentation, from an entity other than the receiving facility, of verification activities when a supply-chain-applied control is applied by an entity other than the receiving facility's supplier.

Effective Date Note:

At 80 FR 56145, Sept. 17, 2015, 117.475 was added, effective Nov. 16, 2015, except for paragraph (c)(2). FDA will publish a document in the Federal Register announcing the effective date for this paragraph.

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