Case Study : FDA Facility Registration
Client Overview
Company: Sark Spices
Location: TAK-Industrial Complex,Neelamperoor, Kottayam, Kerala, India.
Industry: Food & Spice Manufacturing
Products: Ground spices
Market Objective: Export packaged spices to U.S. distributors and retail partners
The Challenge
Sark Spices had strong production capabilities and international quality certifications. However, when preparing to enter the U.S. market, they encountered significant regulatory obstacles.
Their primary pain points included:
- Difficulty obtaining and validating a DUNS number
- Confusion navigating FDA Industry Systems (FIS)
- Lack of clarity around 21 CFR Part 1 requirements
- Inability to find a knowledgeable U.S. Agent
- Uncertainty about spice-specific labeling rules
- Fear of shipment rejection or customs delays
Months of attempted self-registration resulted in stalled progress and growing frustration.
As Mr.Thomas explains:
“Entering the U.S. market felt like an impossible mountain of paperwork. We struggled for months with our DUNS number and finding a reliable U.S. Agent who actually understood the spice industry.”
Our Approach
FDA Consults implemented a structured, four-stage compliance framework to transition the client from uncertainty to full regulatory readiness.
Step 1 — Regulatory Audit & Gap Analysis
We began by conducting a detailed compliance review of the client’s existing FSSAI documentation, facility licenses, and internal records. Our team mapped these records against U.S. regulatory requirements under 21 CFR Part 1 (Food Facility Registration requirements). This gap analysis identified critical differences between Indian regulatory documentation and FDA expectations, particularly in:
- Facility identification details
- Ownership disclosure
- Registration timing
- Record maintenance requirements
This step created a clear regulatory roadmap.
Step 2 — DUNS Registration & FDA Food Facility Registration (FFR)
The absence of a properly aligned DUNS record was causing delays. FDA Consults coordinated the DUNS validation process and ensured consistency across business identifiers.
We then:
- Created and configured the FDA Industry Systems (FIS) account
- Verified facility activity classification
- Entered accurate operational details
- Completed the official Food Facility Registration (FFR)
- Conducted internal data validation prior to submission
The registration was successfully submitted and activated without rejection or resubmission.
Step 3 — U.S. Agent Appointment & Communication Bridge
FDA regulations require foreign facilities to designate a U.S.-based Agent.
FDA Consults stepped in as the official U.S. Agent, providing:
- 24/7 regulatory communication monitoring
- Immediate forwarding of FDA correspondence
- Structured response guidance
- Inspection communication coordination
Being located near FDA headquarters provided additional assurance of responsiveness and regulatory familiarity.
Step 4 — Labeling Compliance for Spice Exports
Spice products have specific U.S. labeling expectations, particularly regarding:
- Ingredient order
- Product identity statements
- Net quantity declarations
- Nutrition Facts formatting (when applicable)
- Country of Origin disclosure
We reviewed Spark Spice’s packaging and provided targeted recommendations to reduce the risk of import holds or relabeling costs.
The Results
Within a short timeframe, the client achieved:
✅ Active FDA Facility Registration
✅ Valid DUNS alignment
✅ Official U.S. Agent designation
✅ Improved labeling clarity
✅ Export-ready documentation
✅ Successful U.S. shipment clearance
Most importantly, the client gained confidence in their regulatory foundation.