Your Gateway to U.S. Market Success
Comprehensive FDA compliance and U.S. market entry support for food companies, manufacturers, and importers.
Comprehensive FDA Compliance Services
We help businesses ensure their food labels meet all FDA requirements, including nutrition facts, allergens, ingredients, and claims.
Regulatory Compliance & Advisory
- Interpretation of FDA regulations (CFR Title 21)
- Product classification (food vs supplement vs drug vs cosmetic)
- Guidance on FSMA compliance
- Regulatory strategy for new product launches
- Warning letter and enforcement risk assessment
Food Safety (FSMA / FSVP)
- Development of Foreign Supplier Verification Programs (FSVP)
- Acting as or supporting the FSVP Qualified Individual (QI)
- Hazard Analysis (biological, chemical, physical hazards)
- Supplier approval & verification programs
- Reevaluation procedures and documentation
- FDA audit preparation and support
Labeling Compliance & Development
- Full FDA label reviews (21 CFR 101, 117, etc.)
- Creation of compliant Nutrition Facts Panels
- Ingredient statement corrections (order, sub-ingredients, allergens)
- Claims review (e.g., “natural,” “healthy,” structure/function claims)
- Bilingual label compliance (English/Spanish)
- Supplement Facts vs Nutrition Facts determination
Import / Export FDA Compliance
- FDA product code determination
- Prior Notice compliance
- Import detention and refusal support
- Reconditioning strategies (FDA Form 766)
- Import Alert removal petitions
- Coordination with FDA inspectors and compliance officers
Facility Registration & U.S. Agent Services
- FDA Food Facility Registration (FFR)
- Acting as U.S. Agent for foreign facilities
- Biennial renewals and updates
- DUNS and FDA system alignment issues
Documentation & SOP Development
- Creation of:
- SOPs (Standard Operating Procedures)
- Food safety plans
- Hazard analysis documents
- Recall plans
- Traceability programs
- Audit-ready documentation systems
Audits & Inspection Support
- Mock FDA inspections
- Gap analysis audits
- Response to FDA Form 483 observations
- Corrective action plans (CAPA)
- On-site or remote audit support
Product Development & Claims Strategy
- Ingredient compliance verification
- GRAS determination support
- Review of additives, colors, preservatives
- Structure/function claim substantiation
- Avoiding drug classification issues (e.g., “detox” claims)
Cosmetics & Personal Care Compliance
- Ingredient review (prohibited/restricted substances)
- Label compliance (21 CFR 701)
- Color additive compliance
- MoCRA readiness (modern cosmetic regulation updates)
Training & Education
- FDA compliance training programs
- FSMA / FSVP training for staff
- Labeling workshops
- Internal compliance training systems
Crisis & Enforcement Support
- FDA Warning Letter responses
- Import detention strategy
- Recall management
- Product seizure or refusal mitigation
Cross-Border (FDA + Customs) Consulting (your niche advantage)
- FDA + CBP alignment (country of origin, manufacturer definition)
- Tariff classification impact on FDA requirements
- PGA (Participating Government Agency) coordination
- Entry review for FDA compliance before filing
Why Choose Burge FDA Group
- Experienced FDA consultants
- Fast response times
- Support for international companies
- End-to-end market entry guidance
