Hazard Analysis - HACCP Plan

A fully documented Hazard Analysis and Critical Control Points (HACCP) Plan is essential for dietary supplement facilities governed by 21 CFR Part 117 under the FSMA Preventive Controls for Human Food rule. It helps identify, prevent, and control food safety hazards—ensuring your operation is FDA-compliant and audit-ready.

Who Needs It?

    • Dietary Supplement Manufacturers processing, blending, encapsulating, or packaging supplements

    • Foreign Suppliers shipping to the U.S. under FSVP compliance

    • Private Label Brands working with contract manufacturers

    • Facilities seeking certification under SQF, FSSC, or ISO-based systems

Why It’s Required:

    • Core requirement of FDA’s Food Safety Modernization Act (FSMA)

    • Required during FDA inspections, FSVP reviews, and importer audits

    • Mandated by major retailers, distributors, and eCommerce platforms

    • Serves as the foundation of your preventive controls program

What’s Included:

    • Full Hazard Analysis (biological, chemical, and physical hazards)

    • Facility-Specific HACCP Plan Development

    • Identification of Critical Control Points (CCPs)

    • Monitoring, Verification & Corrective Action Procedures

    • Recordkeeping Templates & Document Package

    • PCQI Oversight & Approval (as needed)

What’s Included:

    • FDA Facility Registration (New or Renewal)

    • U.S. Agent Appointment (for foreign facilities)

    • Registration Confirmation and Number

    • Biennial Renewal Reminders & Monitoring

    • FDA Compliance Guidance & Support

Pricing:

Service Standard Price Support360 Member Price (50% Off)
HACCP Plan + Hazard Analysis Setup $3,000 $1,500
    Support360 Members save 50% on all food safety documentation and compliance services. Join now to unlock expert guidance at exclusive rates.

Avoid Compliance Gaps:

    Without a HACCP plan, your facility could face:

      • FDA 483s, warning letters, or inspection delays

      • Rejected shipments and customs detentions

      • Non-approval by Amazon, Walmart, or wholesale buyers

      • Certification and FSVP audit failures

    At DietarySupplements.pro, we simplify HACCP compliance by delivering a customized, ready-to-use food safety plan that aligns with your operation—fast, effective, and FDA-focused.
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