Service overview
We audit your FSMA compliance, develop HARPC plans, and prepare your FSVP and cGMP records for FDA review.
Why this service matters
- FSMA focuses on preventing food safety problems rather than reacting to them.
- Supplement companies must meet HARPC, FSVP, cGMP and food defence requirements.
- Non-compliance can lead to import holds, recalls, destruction orders and fines.
FSMA Compliance Gap Assessments
We audit your processes, documentation and controls to identify gaps in FSMA compliance.
- Assessment of existing food safety plans and processes
- Evaluation of HARPC implementation and preventive controls
- FSVP readiness audits for imported dietary supplements
Food Safety Modernization Act (FSMA) Compliance
Hazard Analysis & Risk-Based Preventive Controls Development
Under FSMA, dietary supplement manufacturers need HARPC plans, and we help develop plans tailored to your products.
- Risk identification and hazard analysis specific to dietary supplements
- Corrective action procedures to address deviations
- Ongoing monitoring and verification systems
Foreign Supplier Verification Program (FSVP) Compliance
FSMA requires importers to verify that foreign suppliers meet US safety standards, and we offer FSVP Agent services and supplier compliance management.
- Acting as your designated FSVP Agent for FDA compliance
- Documentation management for supplier safety records
- Audit support and FDA inspection readiness
cGMP Compliance Support for FSMA Alignment
Current Good Manufacturing Practices (cGMPs) under 21 CFR Part 111 are a core FSMA requirement, and we help align your manufacturing with them.
- GMP audits of manufacturing, packaging, and distribution facilities
- Quality control and product testing protocol reviews
- Corrective action plans to address GMP deficiencies
Supply Chain Programme Development & Management
FSMA expects a supply chain programme that sources ingredients from verified suppliers, and we help build and manage yours.
- Supplier approval and monitoring programmes
- Ingredient traceability and verification systems
- Third-party audit coordination for supplier facilities
FSMA Documentation & Record-Keeping Solutions
FSMA requires detailed record-keeping, and we help manage your documentation for FDA inspections.
- Digital storage of all FSMA-related documentation
- HARPC and FSVP compliance records management
- Audit-ready reporting tools for FDA inspections
Ongoing compliance support
Time-Saving
A clear gap assessment shows what needs attention, so effort goes where it matters.
Regulatory Assurance
HARPC, FSVP and cGMP obligations addressed together in one compliance plan.
Peace of Mind
Reduce the risk of import holds, recalls and penalties linked to FSMA non-compliance.
What you'll need
An FSMA gap assessment works from what you already have in place.
- Current food safety planExisting plans and processes to assess.
- Preventive controlsHow HARPC is implemented today.
- Supplier approval recordsHow suppliers are approved and monitored.
- Traceability dataIngredient traceability and verification.
Official sources
- 21 CFR Part 117: CGMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food (eCFR)
- 21 CFR Part 121: Mitigation Strategies to Protect Food Against Intentional Adulteration (eCFR)
- 21 CFR Part 1 Subpart L: Foreign Supplier Verification Programs (eCFR)
- FSMA Final Rule on Foreign Supplier Verification Programs for Importers (FDA)
- 21 CFR 101.36: Nutrition labeling of dietary supplements (eCFR)
- 21 CFR Part 111: CGMP for dietary supplements (eCFR)
- Dietary Supplements (FDA)