$2,000/day

FDA Inspection Support

FDA Inspection
Readiness and Support

We get your site ready for an FDA inspection, and when the investigator arrives we can be in your back room or on call, managing document requests, preparing your people for each day and making sure nothing is said or handed over that should not be.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
$2,000/day
Published price
Back room
During FDA
Daily
Debriefs
Jared Clark, FDA Inspection Readiness and Support consultant

What you get

Someone who has been through it, beside you

Most companies face FDA a handful of times in a decade. The people in the room have often never done it. This is what an experienced hand changes.

A readiness program

A gap review against the regulations that apply, a written inspection procedure, a trained front room team, a document index that can produce any record in minutes, and storyboards for your known weak spots.

Back room support

During the inspection we run the back room: retrieving and reviewing every document before it goes to the investigator, tracking every request and copy, and preparing the next subject-matter expert.

Daily debriefs

At the end of each day, a debrief on what the investigator asked, where they are heading, what could become an observation, and what to correct on the spot.

Closing meeting preparation

Preparation for the closing meeting so that your responses to each observation are accurate and on the record, and the 15-business-day response clock starts with a plan already drafted.

How It Runs

Three steps

1

Ready

A readiness assessment, then the procedure, the team training and the document index. For sites that want a rehearsal, a mock FDA inspection closes this phase.

2

During

When FDA arrives you call us. Depending on the arrangement we come to site or support remotely from the first day, for as long as the inspection runs.

3

After

Help writing the Form 483 response, so it reaches FDA within 15 business days and is considered before any decision about a warning letter.

Scope

What readiness covers

FDA inspections are often unannounced for food and supplements, and for drugs they may come with only a few days' notice. Readiness therefore cannot be a project that starts when the investigator calls. We build it into the way the site works: who greets the investigator, who escorts, which room they use, how requests are logged, who may answer which questions, and how records are reviewed before release.

For OTC drug, dietary supplement, cosmetic and food sites we also check the things that are easy to miss before an inspection: drug establishment registration and listing under 21 CFR Part 207, facility registration for food and cosmetics, the status of any open complaints or recalls, and whether the labels on the shelf match the records.

If FDA has asked for records instead of visiting, see FDA remote regulatory assessments.

A good fit

  • You expect a first FDA inspection, a pre-approval inspection, or a re-inspection after a 483.
  • Your quality team has never hosted an FDA investigator and wants someone in the back room who has.
  • You want an on-call arrangement so that support starts on the first morning of an unannounced inspection.

Not the right service

  • –You want someone to speak to FDA on your behalf as if they were your employee. The investigator will talk to your people; our job is to make sure they are ready.

Price And Terms

$2,000 per day during an inspection; readiness as a fixed fee

Every engagement is priced in writing after a free 30-minute call and before any work starts. On-site work is scheduled in full days; travel from Salt Lake City is billed at cost, with no markup, after the visit. You own every report and record we produce.

Readiness work is quoted as a fixed fee. Inspection support is billed per day for as long as FDA is on site, with an on-call retainer available for sites that cannot wait for travel to be booked.

Frequently asked questions

What does FDA inspection support cost?

Support during an inspection is $2,000 per day for as long as FDA is on site, plus travel at cost. Readiness work before an inspection is quoted as a fixed fee once we have seen the site.

How much notice does FDA give before an inspection?

It varies. Domestic food and dietary supplement inspections are often unannounced. Drug inspections are frequently pre-announced a few days ahead, and pre-approval inspections are usually scheduled. Plan as though the investigator could arrive tomorrow.

What is a front room and back room?

The front room is where the investigator sits with your host and subject-matter experts. The back room is where documents are retrieved, reviewed and copied before they are handed over, and where the next person is prepared. A well-run back room is the single biggest difference between a calm inspection and a chaotic one.

Can a consultant be present during an FDA inspection?

Yes, as part of your team. Consultants commonly run the back room, and can sit in the front room when the company invites them. The investigator directs questions to your employees, and the consultant should not answer for them.

How long do we have to respond to a Form 483?

FDA considers a written response received within 15 business days of the inspection's close before deciding whether to issue a warning letter. A response that arrives later may still be read, but it may not count in that decision.

Your Consultant

Who does the work

Jared Clark, our principal consultant, leads every engagement. He has spent his career in quality systems, FDA liaison work and regulatory affairs for pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers, and founded Certify Consulting in 2016. He holds the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP) certifications, and has worked through certification and surveillance audits alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars. His full credentials and their verification links are on the About page.

Related Services

Often paired with this one

Mock FDA Inspection

We inspect your site the way FDA would and give you a mock Form 483 while there is time to fix it.

Form 483 and Warning Letter Response

A Form 483 or warning letter response with real root causes and evidence, inside 15 business days.

FDA Remote Regulatory Assessments

Help answering an FDA records request or remote assessment, and closing the gaps it exposes.

Get ready before the call comes

Book a free 30-minute call about readiness, or call 858-240-4353 directly if an investigator has just arrived.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting