Description
Determination of Status as a Qualified Facility under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Scope & Applicability
Product Classes
4Food intended for human consumption subject to Part 117; Food manufactured, processed, packed, or held
Food 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
A facility status defined under part 117 subject to specific modified requirements.
A business category defined by annual human food sales and market value thresholds.
Stakeholders
10A facility subject to modified requirements based on size or sales; Status based on sales and market value thresholds; A facility that is a very small business or meets specific sales criteria to qualified end-users; Facility type eligible for modified requirements
Entity manufacturing animal food without sale
Manufacturer/processor covered by preventive controls requirements; Manufacturer/processor receiving ingredients from a supplier
Facility supplying raw materials or ingredients; Facility providing raw materials to a manufacturer
A business averaging less than $1,000,000 in annual sales of human food; Definition based on average annual sales plus market value; Business averaging less than $2,500,000 in annual sales of animal food
A consumer, restaurant, or retail food establishment meeting specific location criteria; Consumer of food or a restaurant/retail food establishment within specific distance
An entity that may meet the definition of a very small business independently of its parent.; Company owned or controlled directly or indirectly by another company
An entity whose sales must be included in the calculation if it is related to the facility.; Facility that controls, is controlled by, or is under common control with another facility
A facility that processes food for a fee, such as spice irradiation.
A facility that packages food for a fee.
Regulatory Context
Attributes
5Value of food held without sale used for status calculations; Value of food manufactured, processed, packed, or held; Value of food manufactured, processed, packed, or held without sale; Calculated based on commodity price for broiler feed
Threshold posted on FDA website for status determination
Financial metric for determining business size status
Financial threshold for determining facility status
The $1,000,000 limit used to determine very small business status.; The $2,500,000 limit for very small businesses adjusted for inflation
Identified Hazards
Hazards
1Outbreaks of this hazard may trigger a for-cause inspection.; Outbreak associated with food produced at a facility; Outbreak associated with animal food triggering for-cause inspection; Risk associated with outbreaks triggering for-cause inspections
Related CFR Sections (13)
- 21CFR1.227§ 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
- 21CFR507.130§ 507.130 Conducting supplier verification activities for raw materials and other ingredients.
(a) Except as provided by paragraphs (c) , (d) , or (e) of this section, one or more of the supplier verification activities specified in § 507.110(b) , as determined under § 507.110(d) , must be conducted for each supplier before using the raw material or other ingredient from that supplier and perRead full regulation →
- 21CFR507.105§ 507.105 Requirement to establish and implement a supply-chain program.
- 21CFR507.200§ 507.200 Records subject to the requirements of this subpart.
(a) Except as provided by paragraphs (d) and (e) of this section, all records required by this part are subject to all requirements of this subpart.Read full regulation →
- 21CFR507.7§ 507.7 Requirements that apply to a qualified facility.
(a) A qualified facility must submit the following attestations to FDA:Read full regulation →
- 21CFR507.3§ 507.3 Definitions.
The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:Read full regulation →
- 21CFR117.201§ 117.201 Modified requirements that apply to a qualified facility.
(a) Attestations to be submitted. A qualified facility must submit the following attestations to FDA:Read full regulation →
- 21CFR117.3§ 117.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:Read full regulation →
- 21CFR117.320§ 117.320 Requirements for official review.
All records required by this part must be made promptly available to a duly authorized representative of the Secretary of Health and Human Services for official review and copying upon oral or written request.Read full regulation →
- 21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .Read full regulation →
- 21CFR117.405§ 117.405 Requirement to establish and implement a supply-chain program.
- 21CFR117.430§ 117.430 Conducting supplier verification activities for raw materials and other ingredients.
(a) Except as provided by paragraph (c) , (d) , or (e) of this section, one or more of the supplier verification activities specified in § 117.410(b) , as determined under § 117.410(d) , must be conducted for each supplier before using the raw material or other ingredient from that supplier and periRead full regulation →
- 21CFR1.230§ 1.230 When must you register or renew your registration?
(a) Registration. You must register before your facility begins to manufacture, process, pack, or hold food for consumption in the United States. You may authorize an individual to register the facility on your behalf.Read 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
- 2025-08-26
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
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
See Also (8)
- Draft Guidance for Industry: Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5) (Status: Final)
- CPG Sec 100.250 Food Facility Registration (Human and Animal Food) (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration (Status: Draft)
- Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government (Status: Final)