Description
This guidance is intended for persons who participate in certain “co-manufacturing” agreements in the production of human or animal food. By “co-manufacturing,” we mean a contractual arrangement whereby one party (the brand owner) arranges for a second party (the co-manufacturer) to manufacture/process human or animal food on behalf of the first party.
Scope & Applicability
Product Classes
2Food intended for animal consumption subject to Part 507; Food for animal consumption manufactured, processed, packed, or held; Subject of the preventive controls regulation; Product manufactured by contract feed mills
Food intended for human consumption subject to Part 117; Food manufactured, processed, packed, or held
Stakeholders
5Must comply with registration if meeting facility/responsible person definitions
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
Entity responsible for approving suppliers and conducting verification; A facility that manufactures/processes a raw material or other ingredient received from a supplier; entity that manufactures/processes food and receives ingredients; Entity responsible for reviewing and assessing documentation from other entities; Facility that receives raw materials or ingredients; Entity responsible for reviewing supplier documentation
Entity that owns the food brand and may conduct supplier approval
Contract manufacturer/processor receiving facility
Identified Hazards
Hazards
1Preventive control for a hazard in a raw material controlled before receipt
Related CFR Sections (9)
- 21CFR507.120§ 507.120 Using approved suppliers.
(a) The receiving facility must approve suppliers in accordance with the requirements of § 507.110(d) , and document that approval, before receiving raw materials and other ingredients received from those suppliers;Read full regulation →
- 21CFR117.420§ 117.420 Using approved suppliers.
(a) Approval of suppliers. The receiving facility must approve suppliers in accordance with the requirements of § 117.410(d) , and document that approval, before receiving raw materials and other ingredients received from those suppliers;Read full regulation →
- 21CFR1.502§ 1.502 What foreign supplier verification program (FSVP) must I have?
(a) General. Except as specified in paragraph (b) of this section, for each food you import, you must develop, maintain, and follow an FSVP that provides adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same leRead full regulation →
- 21CFR507.110§ 507.110 General requirements applicable to a supply-chain program.
(a) The supply-chain program must include:Read full regulation →
- 21CFR117.410§ 117.410 General requirements applicable to a supply-chain program.
(a) The supply-chain program must include:Read full regulation →
- 21CFR507.115§ 507.115 Responsibilities of the receiving facility.
- 21CFR117.415§ 117.415 Responsibilities of the receiving facility.
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR1.509§ 1.509 How must the importer be identified at entry?
(a) You must ensure that, for each line entry of food product offered for importation into the United States, your name, electronic mail address, and unique facility identifier recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entryRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Animal Food/Adulterated
King Farm
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC
- 2025-07-08
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Lystn LLC dba Answers Pet Food
See Also (8)
- CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)