What Does an FDA U.S. Agent Do for Inspections?

The U.S. Agent's Role in Inspection Communications

When FDA decides to inspect your foreign facility, they don't call you directly—they contact your U.S. Agent first. This is where many companies realize the difference between a basic forwarding service and an inspection-ready agent.

Here's what actually happens: FDA sends an inspection notice to your agent's address, usually via postal mail but sometimes email. The notice includes the proposed inspection dates, what FDA wants to see, and any preliminary questions. Your agent receives this, and ideally forwards it to you within 24-48 hours (though some guarantee same-day forwarding).

But it's not just about forwarding mail. FDA may also call your agent's phone number for urgent matters—maybe they need to reschedule, or there's a last-minute question. If your agent doesn't answer or doesn't have a reliable phone number, you might miss critical updates. We've seen companies miss inspection scheduling calls because their agent's phone went to voicemail and wasn't checked for days.

Inspection scheduling coordination is where good agents really earn their keep. They help coordinate dates, understand your time zone constraints, and ensure you're prepared. A basic agent just forwards the notice and says "good luck." A good agent helps you understand what to expect, what documents FDA might request, and how to prepare. This is especially valuable if you're not familiar with FDA inspection processes.

Important clarification: Your U.S. Agent doesn't attend the inspection or answer FDA's questions on your behalf. They're a communication channel, not a regulatory representative. FDA will still inspect your facility directly, and you'll need to respond to their questions yourself. But having an agent who forwards communications promptly and helps coordinate logistics makes the whole process smoother.

Emergency situations expose the difference between providers. If FDA issues an urgent inspection notice (maybe related to a recall or safety issue), a basic agent forwards it the next business day. A premium agent with 24/7 support might call you immediately, even if it's the middle of the night in your time zone. For urgent inspections, those extra hours can matter significantly.

What "Good" Looks Like (SLA, Escalation, Time Zones)

After working with dozens of companies through FDA inspections, here's what separates inspection-ready agents from basic forwarding services.

Response time SLAs matter more than you'd think. A good agent guarantees same-day or 24-hour forwarding for inspection notices. We've seen companies get inspection notices on Friday afternoon, and agents with 48-hour SLAs don't forward them until Tuesday. By then, you've lost valuable preparation time. Premium agents offer same-hour forwarding for urgent matters, which is worth the extra cost if timing is critical.

Escalation procedures prevent disasters. What happens if your agent misses a communication? Good agents have documented backup procedures—maybe a secondary contact, or a team member who checks if the primary contact is unavailable. Solo consultants don't have this, which creates risk. We've heard stories of solo agents going on vacation and missing critical inspection notices.

Time zone coverage is crucial. If you're in Asia and FDA calls at 9 AM Eastern time, that's evening for you. Your agent needs to be available during U.S. business hours (Eastern, Central, Pacific). Some providers offer 24/7 emergency support, which is valuable for urgent inspection matters. Basic agents might only check email once a day, which isn't enough for time-sensitive inspections.

Team redundancy beats solo operations. Team-based providers have multiple people who can handle communications. If one person is unavailable, someone else steps in. Solo consultants create single points of failure. For inspections, where timing matters, redundancy is worth paying for.

Documented procedures show professionalism. Good agents have clear, written procedures for handling inspection communications. They know how to prioritize urgent notices, what information to include when forwarding, and how to escalate if needed. Generic mailbox services don't have this—they just forward everything blindly.

Inspection coordination goes beyond forwarding. Basic agents forward the notice and that's it. Good agents help coordinate dates, understand your scheduling constraints, provide preparation checklists, and may even join pre-inspection calls with FDA. This extra support typically costs $300-500/year more, but it's invaluable if you're not familiar with FDA inspection processes.

Inspection-Support Add-Ons (What's Legit vs Fluff)

Some providers try to upsell inspection support services. Here's what's actually valuable versus what's just marketing fluff.

Legitimate: Inspection scheduling assistance. This is real value. A good agent helps coordinate dates, understands your time zone constraints, and ensures FDA has the right contact information. They might even join pre-inspection calls to help facilitate communication. This typically costs $200-400/year extra and is worth it if you're not familiar with FDA processes.

Legitimate: Pre-inspection preparation guidance. Some agents provide checklists, common questions FDA asks, and tips for preparing your facility. This isn't regulatory consulting (which would cost more), but basic preparation help. Useful if you're a first-time registrant. Usually included in premium packages or costs $100-200/year as an add-on.

Legitimate: Post-inspection communication forwarding. After inspections, FDA sends 483s (inspection observations), inspection reports, and follow-up communications. Your agent should forward these promptly. This is basic service, but some providers charge extra for "priority forwarding" of post-inspection communications. That's usually worth it if you need fast turnaround on 483 responses.

Fluff: "Inspection representation." Some providers claim they'll "represent you" at inspections. That's misleading—U.S. Agents don't attend inspections or represent you. FDA inspects your facility directly, and you respond to their questions. If a provider claims this, they're either confused about the role or trying to upsell unnecessary services.

Fluff: "Guaranteed inspection pass." No agent can guarantee inspection outcomes. FDA makes those decisions based on your facility's compliance, not your agent. If someone promises this, run away—they're either dishonest or don't understand FDA processes.

Fluff: "Inspection consulting" bundled with basic service. Real inspection consulting (helping you prepare, reviewing documents, providing regulatory advice) is valuable but should be priced separately. If an agent claims to include "consulting" in a $500/year package, they probably mean basic forwarding with some tips. That's fine, but don't expect full regulatory consulting at that price.

Bottom line: The core U.S. Agent role is communication forwarding. Additional services like scheduling assistance and preparation guidance are valuable, but they should be clearly defined and priced transparently. Don't pay premium prices for services that are just basic forwarding with fancy names.