• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

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).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2018]
[CITE: 21CFR117.415]



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. 117.415 Responsibilities of the receiving facility.

(a)(1) The receiving facility must approve suppliers.

(2) Except as provided by paragraphs (a)(3) and (4) of this section, the receiving facility must determine and conduct appropriate supplier verification activities, and satisfy all documentation requirements of this subpart.

(3) An entity other than the receiving facility may do any of the following, provided that the receiving facility reviews and assesses the entity's applicable documentation, and documents that review and assessment:

(i) Establish written procedures for receiving raw materials and other ingredients by the entity;

(ii) Document that written procedures for receiving raw materials and other ingredients are being followed by the entity; and

(iii) Determine, conduct, or both determine and conduct the appropriate supplier verification activities, with appropriate documentation.

(4) The supplier may conduct and document sampling and testing of raw materials and other ingredients, for the hazard controlled by the supplier, as a supplier verification activity for a particular lot of product and provide such documentation to the receiving facility, provided that the receiving facility reviews and assesses that documentation, and documents that review and assessment.

(b) For the purposes of this subpart, a receiving facility may not accept any of the following as a supplier verification activity:

(1) A determination by its supplier of the appropriate supplier verification activities for that supplier;

(2) An audit conducted by its supplier;

(3) A review by its supplier of that supplier's own relevant food safety records; or

(4) The conduct by its supplier of other appropriate supplier verification activities for that supplier within the meaning of 117.410(b)(4).

(c) The requirements of this section do not prohibit a receiving facility from relying on an audit provided by its supplier when the audit of the supplier was conducted by a third-party qualified auditor in accordance with 117.430(f) and 117.435.

-
-