$6,000–$12,000

Inspection Readiness

Mock FDA
Inspection

We inspect your facility the way an FDA investigator would, from the arrival at the front desk to the closing meeting, and hand you a mock Form 483 with the observations FDA would most likely write, while there is still time to fix them.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
$6,000–$12,000
Published price
Mock 483
Before FDA's
Live
Interview practice
Jared Clark, Mock FDA Inspection consultant

What you get

FDA's view of your site, before FDA arrives

A checklist audit tells you whether the procedures exist. A mock inspection tells you what happens when an investigator asks for them, at 3 p.m., on second shift. This is what you get.

A mock Form 483

The observations an investigator would most likely write, in FDA's wording, each tied to the regulation and the evidence. Read the list the way FDA would and you know where you stand.

A readiness report

Beyond the 483: the weaker areas that might not be cited this time, the records that took too long to produce, and the people who were not ready to answer.

Interview practice

Your supervisors, operators and quality staff are interviewed the way investigators interview them, then coached on answering accurately, briefly and without guessing.

A logistics test

Front room, back room, document requests, escorts and copies: we test how your inspection procedure actually runs and fix what breaks.

How It Runs

Three steps

1

Prepare

A document request like the one FDA sends before a pre-approval or for-cause inspection, a review of your last inspection history, and agreement on which systems the mock inspection will cover.

2

Inspect

One to three days on site following FDA's own inspection approach, which looks at the quality system first and then the production, facilities and equipment, laboratory, materials, and packaging and labeling systems.

3

Close

A closing meeting with a mock 483 read aloud, the written report within a week, and a prioritized plan for the observations.

Scope

How a mock inspection is run

We follow the method FDA investigators are trained to use. For drugs, including OTC, that is the systems-based approach in FDA's compliance program for drug manufacturing inspections: quality, facilities and equipment, materials, production, packaging and labeling, and laboratory controls. For dietary supplements it is 21 CFR 111. For food it is 21 CFR 117 and your food safety plan. The facility walk comes first because it is where investigators decide what to look at in the records.

We push where FDA pushes: investigations and out-of-specification results that were closed without a real root cause, complaints that should have been investigations, cleaning and process validation, data integrity in the laboratory, change control, supplier qualification, and training records that do not match what people actually do.

After a real inspection, the Form 483 and warning letter response service takes over. Before one, see the GMP audit preparation guide.

A good fit

  • You have never been inspected by FDA, or not since you added a new product category such as OTC drugs.
  • FDA has sent a records request or announced an inspection and you want a rehearsal first.
  • Your last inspection ended in a 483 and you want to know the fixes will hold before FDA comes back.
  • A new quality leader wants an outside baseline of where the site really stands.

Not the right service

  • –You want a guarantee of no 483. Nobody can give that honestly; we can tell you what is most likely to be written.
  • –FDA is already in the building. Then you need inspection support, not a mock inspection.

Price And Terms

$6,000 to $12,000, quoted in writing before we start

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.

Most sites take two days on site; a single-product site can be done in one, and a multi-building or multi-shift site may need three. The fee covers preparation, the days on site, the mock 483 and the report.

Frequently asked questions

What does a mock FDA inspection cost?

$6,000 to $12,000, depending on whether it takes one, two or three days on site. The fee covers preparation, the days on site, the mock Form 483 and the written report. Travel is billed at cost.

What is a mock FDA inspection?

A rehearsal of a real one. An experienced auditor plays the investigator, follows FDA's inspection approach, requests documents, interviews staff, walks the floor and ends with a mock Form 483. Its value is that it tests how the site performs under inspection, not only whether the paperwork exists.

Should the mock inspection be announced to staff?

Usually it is announced to management and lightly announced to the floor, because the goal is to see normal operation, not a staged one. If you want to test your front desk and escort procedure, we can arrive unannounced on an agreed day.

Is a mock inspection the same as an internal audit?

No. An internal audit checks conformance clause by clause and is required by ISO standards. A mock inspection reproduces the pressure and the path of an FDA inspection, including interviews and document turnaround, and is graded the way FDA grades. Many sites need both.

How soon before an inspection should we do one?

Three to six months before, if you know it is coming, so there is time to fix what is found. If FDA has already announced an inspection, a short mock inspection in the weeks before it is still worth doing for the interview practice alone.

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

FDA Inspection Readiness and Support

Ready before FDA arrives, and an experienced hand in your back room while the investigator is there.

FDA Remote Regulatory Assessments

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

Form 483 and Warning Letter Response

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

Rehearse before FDA arrives

Book a free 30-minute call. Tell us what you make and when you expect FDA, and we will propose dates and a fixed fee in writing.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting