Food Safety Command Center 13 items
Foreign Supplier Verification Onsite Audit Checklist
Conduct or review an onsite verification audit of a foreign supplier to satisfy FSVP importer obligations for hazard control.
21 CFR 1 Subpart LFSVP
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Audit Basis and Scope
- Was the onsite audit selected as the verification activity because a hazard has a reasonable probability of causing serious adverse health consequences or death (SAHCODHA)? *
- Does the audit cover the foreign supplier's processes and procedures for controlling the hazards requiring a control? *
- Was the audit conducted within the appropriate timeframe (e.g., before importing and at least annually thereafter)? *
- Audit date
Auditor Competency
- Was the audit performed by a qualified auditor who is not employed by the foreign supplier being audited? *
- Is documentation of the auditor's qualifications and training retained? *
- Is auditor independence and freedom from conflict of interest documented?
Regulatory and Control Review
- Was the foreign supplier's compliance with applicable FDA food safety regulations (or the country's equivalent, where applicable) evaluated? *
- Were the supplier's preventive controls or produce safety measures reviewed for effective implementation? *
- Were monitoring records, corrective actions, and verification records reviewed onsite?
Findings and Corrective Action
- Were any deficiencies documented with a corrective action plan and follow-up dates? *
- Was a written audit report obtained and reviewed by the importer? *
- Were results used to reassess the supplier's approval status? *
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