Records to be ready for inspection by FDA

Record Requirement

Section 21 CFR 1.502 - What foreign supplier verification program (FSVP) must I have?
All importers of human and animal food must develop, maintain, and follow an FSVP for each food and foreign supplier (1.502(a))

1.502 Records: Importer is subject to section 418 of FD&C Act (preventive controls) (1.502(c)):

1.502 An importer who is also a manufacturer and is subject to both FSVP and the supply chain program provisions of either the human food or animal food preventive controls regulation (21 CFR 117 subpart G or 21 CFR part 507 subpart E, respectively) may choose to be in compliance with the applicable preventive controls regulation or with FSVP. If the importer chooses to comply with the supply chain provisions of the applicable preventive controls regulation, they are not required to have an FSVP, except must comply with section 1.509.

Section 21 CFR 1.504 – What hazard analysis must I conduct?

1.504Records: Hazard Analysis

1.504 Hazard identification

1.504 Analysis of known or reasonably foreseeable hazards in each food: > Biological, chemical, and physical hazards > Foreseeable hazards that may be present in a food because (i) hazard occurs naturally; (ii) hazard may be unintentionally introduced; or (iii) hazard may be intentionally introduced for purposes of economic gain.

1.504 Hazard evaluation

1.504 Evaluation of identified hazards to assess probability that hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur

1.504 Evaluation of environmental pathogens when a ready-to-eat food is exposed to the environment before packaging and the packaged food does not receive a treatment or otherwise include a control or measure > Consideration of effect of relevant factors on the safety of the finished food for the intended consumer, including: (i) formulation; (ii) condition, function, and design of the establishment and equipment of a typical entity that manufactures/processes, grows, harvests, or raises this type of food; (iii) raw materials and other ingredients; (iv) transportation practices; (v) harvesting, raising, manufacturing, processing, and packing procedures; (vi) packaging and labeling activities; (vii) storage and distribution; (viii) intended or reasonably foreseeable use; and (ix) sanitation, including employee hygiene factors.

1.504 Hazard analysis performed by qualified individual

1.504 OR Records: Hazard Analysis

1.504 Review and assessment of another entity’s hazard analysis

1.504 Include documentation that qualified individual conducted the hazard analysis

1.504Records: Reevaluation

1.504 Reevaluation of the foreign supplier’s performance and risks posed by the food. (Reevaluation if importer obtains new information or concerns relating to foreign supplier or at the end of any 3-year period)

• Actions taken or changes to FSVP based on reevaluation (e.g., discontinue use of foreign supplier, change verification activities)

1.504OR Records: Reevaluation

1.504 Review and assessment of the other entity’s documentation or reevaluation

1.504 Include documentation that qualified individual conducted the hazard analysis

1.504Records: Evaluation of foreign supplier’s performance and risk posed by food

• Document the evaluation of foreign supplier’s performance and risk posed by the food

• Approval of foreign supplier, based on evaluation of foreign supplier’s performance and risk posed by food > Consideration of appropriate and necessary factors, including: (i) hazard analysis, including nature of the hazard requiring a control; (ii) entity or entities that will significantly minimize or prevent hazards requiring a control or verifying that hazards have been significantly minimized or prevented; and (iii) foreign supplier performance

• Reevaluation of supplier approval based on new information relating to factors used as basis for approval, or at least every three years. If concerns relating to importing food from a foreign supplier change, including: > Determination of whether it is appropriate to continue to import the food from the foreign supplier > Determination of whether supplier verification activities need to be changed > Any actions taken based on results of reevaluation

• 1.504 OR Records: Evaluation of foreign supplier’s performance and risk posed by food  Review and assessment of another entity’s evaluation or reevaluation of risk posed by the food and performance of the foreign supplier, including: > Evaluation or reevaluation performed by qualified individual

1.504 Records: Importer develops procedures for importing food only from approved foreign suppliers or importer conducts review and assessment of procedures established by another entity for importing food only from approved foreign suppliers  Procedures for importing food only from approved foreign suppliers

1.504 OR Review and assessment of procedures established by another entity for importing food only from approved foreign suppliers  Use of procedures for importing food from approved suppliers

1.504 Records: Importer develops procedures for importing food from unapproved foreign suppliers or importer conducts review and assessment of procedures established by another entity for importing food from unapproved foreign suppliers  Procedures for importing food from unapproved foreign suppliers, when necessary and appropriate

1.504 OR Review and assessment of procedures established by another entity for importing food from unapproved foreign suppliers when necessary and appropriate

• Use of procedures for importing food from unapproved suppliers

• Procedures for ensuring appropriate verification activities conducted

• Determination of supplier verification activities that will be conducted, including: > Frequency of conducting activity > Entity or entities significantly minimizing or preventing hazard or verifying hazards significantly minimized or prevented > If SAHCODHA hazard, determination that less frequent auditing or alternate verification activity is appropriate rather than an initial and annual onsite audit

1.504 OR Review and assessment of another entity’s determination of appropriate supplier verification activities, including: > Other entity’s determination is appropriate, including frequency > Determination made by qualified individual

1.504 Records: Performance of one or more foreign supplier verification activities

1.504 Onsite audit > Include audit procedures, audit dates, conclusions, corrective actions, performed by qualified auditor o If the food is subject to one or more FDA food safety regulations, must consider applicable FDA food safety regulations or, when applicable, may consider relevant laws and regulations of country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States o Must include review of supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled > Conducted before importing the food and periodically thereafter > Must be performed by entity other than foreign supplier > Results of inspection can be substituted for onsite audit (inspection within 1 year of date audit would have been conducted)

1.504 Sampling and testing of the food > Include number of samples tested, type of tests conducted, dates of tests, date of test report, results, any corrective actions, testing laboratory, performed by qualified individual > Conducted before importing the food and periodically thereafter  Review foreign supplier’s food safety records > Include dates, general nature of records reviewed, conclusions, any corrective actions taken, conducted by qualified individual > Cannot be performed by foreign supplier > Conducted before importing the food and periodically thereafter

1.504 “Other” verification activity - Conduct and document or obtain documentation of other supplier verification activity > Documentation of each activity, including description of activity, date activity conducted, findings or results, any corrective actions taken, and conducted by qualified individual > Conducted before importing the food and periodically thereafter

1.504 OR Review and assessment of results of supplier verification activity performed by another entity > Documentation that appropriate supplier verification conducted for each foreign supplier before importing the food and periodically thereafter > Actions taken if results of verification activity do not provide adequate assurance that hazards requiring a control in the food were significantly minimized or prevented > Foreign supplier itself or its employees may not perform supplier verification activities, except with respect to sampling and testing of food > Not required to retain documentation of verification activity conducted by another entity, but must obtain the documentation and make it available to FDA upon request

Section 21 CFR 1.508 – What corrective actions must I take under my FSVP?

1.508 Corrective actions taken (if applicable)

1.508 Investigations (if applicable)  FSVP modifications (if applicable)

Section 21 CFR 1.509 – How must the importer be identified at entry?

1.509 Importer identification information provided electronically when filing entry with CBP

1.509 Before food is imported or offered for import, if no U.S. owner or consignee, importer designated a U.S. agent or representative as the importer

Section 21 CFR 1.510 – How must I maintain records of my FSVP?

1.510 Records kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records > May use existing records that contain all required FSVP information or may supplement existing records as necessary to include all required information. > Required FSVP information need not be maintained as one set of records (i.e., new FSVP information may be maintained separately or combined with existing records)

1.510 Records signed and dated upon initial completion and any modification

1.510 Records legible and stored to prevent deterioration or loss

1.510 Records available promptly to authorized FDA representative, upon request, for inspection and copying

1.510 English translation provided within a reasonable time, upon FDA request

1.510 Records stored offsite retrieved and provided onsite within 24 hours of FDA request.

1.510 Records sent to Agency electronically, or through another means that delivers the records promptly, upon written FDA request

1.510 Records retained until at least 2 years after created or obtained, or records related to processes and procedures retained for at least 2 years after their use was discontinued.