US FDA Consulting
Food Safety Works offers expert US FDA (U.S. Food & Drug Administration) consulting to help food businesses understand and comply with U.S. food regulations. We guide you through the entire regulatory journey — from facility registration to quality system setup and label review.
Why It Matters
Complying with US FDA regulations is critical if you’re planning to export food products to the U.S. or operate within its regulatory ambit. Our consulting helps:
- Reduce risk during FDA inspections
- Avoid non‑compliance penalties
- Build a food safety system that supports long‑term market entry and consumer trust
How We Help You Succeed
- We map your regulatory journey, tailored to your product and business model.
- Support end-to-end FDA registration and facility setup.
- Develop a tailored food safety plan (FSMA) and deploy a quality management system.
- Train your in-house team (PCQI, audits, compliance).
- Audit your operations for FDA-readiness.
- Review your labels and product claims to ensure they meet U.S. standards.
Contact Us
What We Do
USFDA (Food Facility) Registration
We assist in setting up your FDA Industry System (FIS) account, obtaining a Unique Facility Identifier (DUNS), and registering your food facility.
Compliance Audits & Mock Inspections
Our team conducts internal audits and simulated FDA inspections to identify and address compliance gaps.
Quality Management Systems (QMS)
We help you design and implement a robust QMS aligned with FDA requirements, including preventive controls per FSMA (Food Safety Modernization Act).
PCQI & Regulatory Training
We offer PCQI (Preventive Controls Qualified Individual) training and regulatory workshops to ensure your staff is well-equipped for FSMA compliance.
Product & Label Review
Our experts review product formulations and labels to ensure they comply with FDA regulations, including ingredient safety, permissible claims, and labeling norms.
Gap Assessment Audit (USFDA-focused)
We perform gap audits to benchmark your operations against FDA’s Good Manufacturing Practices (GMPs) and FSMA standards.
Yes. Any facility exporting food to the United States must register with the FDA.
FSMA, or the Food Safety Modernization Act, is a U.S. law focused on preventing food safety issues rather than reacting to them. It’s important because it sets strict safety, hygiene, and preventive control requirements that all food businesses—including exporters to the U.S.—must follow to ensure safe, high-quality food reaches consumers.
PCQI stands for Preventive Controls Qualified Individual — someone trained to prepare and manage food safety plans under FSMA.
Absolutely. We review your product labels against FDA regulations (claims, format, nutrients, allergens, etc.).
Mock inspections simulate FDA inspections so you can identify and fix gaps before they become a real issue.
A gap audit benchmarks your existing operations against FDA expectations — helping you address non-compliance proactively.