Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government

Description

For questions regarding this document contact the Center for Food Safety and Applied Nutrition at240-701-5986, or the Center for Veterinary Medicine at240-402-7001, or the Office of Regulatory Affairs at202-402-4565.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

2

food

Product category subject to refusal of admission

FDA-regulated foods

Foods grown, harvested, manufactured, processed, prepared, packed, or held

Stakeholders

4

FDA investigators

Individuals designated to conduct inspections

owner, operator, or agent in charge

The individual required to sign the Food Defense Plan.

foreign government

Entity that may permit or refuse entry for inspections; Government of the country where the food establishment is located; Entity that may refuse or permit FDA inspections

foreign food establishment

Subject of inspection and potential refusal

Regulatory Context

Regulatory Activities

1

inspection

Ensuring records are accessible for regulatory review

Document Types

4

food labels and labeling

Documentation collected to document potential violations

manufacturing and various control records

Records reviewed during an inspection

FDA Regulatory Procedures Manual

Reference for inspection warrants; Reference for judicial actions and inspection warrants

inspection warrant

Legal document used to compel domestic inspections

Technical Details

Testing Methods

1

collection of samples

Environmental, finished product, raw material, and in-process samples

Identified Hazards

Hazards

2

visible contamination

Contamination of raw materials or finished products

rodents or insect infestation

Conditions documented by photographs during inspection

Related CFR Sections (3)

21CFR1.94§ 1.94 Hearing on refusal of admission or destruction.
(a) If it appears that the article may be subject to refusal of admission or that the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director shall give the owner or consignee a written or electronic noticRead full regulation →
21CFR112.3§ 112.3 What definitions apply to this part?
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 →
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 →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Did not develop, maintain, and follow an FSVP

8

Failure to develop, maintain, and follow an FSVP

5

Failure to develop an FSVP

2

Failing to develop an FSVP for the foods you import

1

Did not develop an FSVP for any of the foods you import

1

Onsite audit did not include required verification activities

1

Adulterated animal food

1

Use of an unapproved/unsafe animal food additive

1

Failure to register food facility

1