Food · Quality Control · Advanced
FDA 21 CFR Part 117 compliance self-assessment covering cGMP, HARPC, allergens, supply chain, and documentation.
US food manufacturers must comply with FDA 21 CFR Part 117 current Good Manufacturing Practice and Preventive Controls. This compliance checklist covers the areas most cited during FDA inspections: cGMP requirements, hazard analysis and risk-based preventive controls (HARPC), allergen controls, supply chain verification, labelling, recall readiness, and recordkeeping.
Regular self-assessments identify potential 483 observations before FDA inspectors find them. Completed checklists support FSMA compliance and GFSI certification readiness.
This checklist template is provided as a general-purpose resource and is not tailored to the regulatory requirements of any specific country, region, or jurisdiction. It is the responsibility of each organisation to review and adapt this template to ensure compliance with all applicable local laws and regulations. Miratag does not accept liability for any inaccuracies or omissions, or for any actions taken based on this template.
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