FSVP Advisors

Beware of Overseas FSVP Sevices

Jan 07, 2026By Homero Ruiz
Homero Ruiz

Why Overseas “FSVP Consultants” Put Your Business at Risk

You may have come across websites or emails from overseas firms — often based in the Philippines, India, or elsewhere — promising to set up your FSVP program for a fraction of U.S. consulting rates. They advertise flashy credentials and quick turnarounds, and to an importer in a hurry, it might sound like a good deal.

It isn’t.

What You Actually Get With Overseas Providers

  1. Cookie-cutter templates that don’t reflect your suppliers, hazards, or operations.
  2. No FDA interface. When the regulator calls, they aren’t in your time zone, and they aren’t trained to answer FDA questions. You’re left holding the bag.
  3. No accountability. They aren’t subject to U.S. law. If FDA finds your program invalid, the importer (you) is 100% responsible — not them.
  4. Surface-level knowledge. They may have read the rules, but they don’t live and breathe U.S. compliance. The nuances of FDA inspections, U.S. buyer expectations, and enforcement culture are completely missing.
     
    The Hidden Costs of “Cheap”
    On paper, you save a few thousand dollars. In reality, you risk:
  • FDA placing your shipments on Import Alert (DWPE).
    Customer contracts terminated when buyers discover you’re non-compliant.
  • Paying double or triple later to clean up the mess when FDA issues a Form 483a or warning letter.
  • Many importers who gamble on overseas consultants eventually call us — but by then, the damage is done and remediation is far more costly.

Why U.S.-Based Expertise Matters:

  • We speak FDA’s language. When the regulator emails or calls, we know how to respond clearly, calmly, and correctly.
  • We’re available when you are. No time-zone delays, no unanswered calls.
  • We understand U.S. expectations. Beyond the letter of the law, we know the cultural, business, and enforcement realities that FDA actually looks for.
  • We stand behind our work. We’re accountable, in the U.S., with credentials and experience that regulators recognize.
     
    Our Position
    We don’t compete with overseas “FSVP consultants.” They play checkers. We play chess.

If you want the cheapest option, they exist elsewhere. If you want your business protected, your shipments cleared, and your reputation intact — you need a U.S.-based professional who can stand between you and FDA with confidence.

That’s where we come in. Don't put your business at risk.

- Homero Ruiz, REHS/RS, PCQI