From $3,500

FDA Records Requests

FDA Remote
Regulatory Assessments

When FDA asks for your records instead of visiting, we help you decide what to send, organize it so it reads well, meet the deadline, and fix the gaps the request exposes before they turn into an inspection finding.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
From $3,500
Published price
Organized
Records package
Gaps closed
Before the visit
Jared Clark, FDA Remote Regulatory Assessments consultant

What you get

A records package that answers the question asked

A remote regulatory assessment is an inspection conducted on paper. What you send, and how it is organized, is the only thing FDA sees. This is how we help.

A read of the request

What FDA is actually asking for, what the regulation requires you to provide, the deadline, and what it suggests about why FDA asked.

The records package

Records gathered, checked for completeness and consistency, indexed, and accompanied by a cover letter that explains what each item is and where to find it.

A gap list

The weaknesses the request exposed, such as missing records, procedures that do not match practice, or registrations that are out of date, ranked by risk.

A plan to close them

The fixes to make before the inspection that often follows a records request, so the investigator finds them already closed.

How It Runs

Three steps

1

Read

Send us the request the day it arrives. We confirm the scope, the deadline, and the legal basis for the request.

2

Assemble

We work with your team to collect, review and organize the records, and draft the cover letter for your signature.

3

Close

After the package goes, the gap list and a plan to close each item before FDA's next contact.

Scope

Remote assessments and records requests

FDA uses remote regulatory assessments to evaluate facilities without, or before, an on-site inspection. For drug manufacturers, including OTC drug sites, section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act lets FDA require records in advance of or in place of an inspection, and refusing or delaying can carry the same consequences as refusing an inspection. Other product types may receive voluntary requests, and FDA has published guidance describing how it conducts them.

A records request is often the first sign that FDA is looking closely at a site. We have helped clients through exactly this situation: a request that was answered, closed out, and still showed the company that its system was not ready for an inspection. The request is worth treating as a free look at where FDA will start.

For an on-site inspection, see FDA inspection readiness and support. For OTC drug quality systems in general, see OTC drug GMP.

A good fit

  • FDA has sent a records request, a 704(a)(4) request, or an invitation to a remote regulatory assessment.
  • You answered a request in the past and want to know whether what you sent created risk.
  • You make OTC drugs and have never had to produce a full set of GMP records for an outside reviewer.

Not the right service

  • –You need legal advice on whether to comply with a request. That is a question for regulatory counsel, and we will work alongside yours.

Price And Terms

From $3,500, quoted the same day you send the request

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.

Fees depend on how many records are requested and how fast they are due. Because these requests come with deadlines, we quote the same day you send the request.

Frequently asked questions

What does help with an FDA records request cost?

From $3,500, depending on how many records FDA asked for and how soon they are due. Because these requests come with deadlines, we quote the same day you send the request.

What is an FDA remote regulatory assessment?

An evaluation of a facility that FDA carries out without being on site, by requesting and reviewing records, and sometimes through video calls or livestreamed walk-throughs. Some are mandatory, such as records requests to drug establishments under section 704(a)(4), and some are voluntary.

Do we have to respond to a 704(a)(4) records request?

For drug establishments, yes. The law lets FDA require the records, and delaying, limiting or refusing a request can be treated like refusing an inspection, which can make your products adulterated. Respond within the time FDA gives, and ask for clarification early if the scope is unclear.

Does a records request mean an inspection is coming?

Not always, but often. FDA uses records reviews to decide where to inspect and what to look at when it does. It is sensible to assume the investigator will arrive having read everything you sent.

Can we send more than FDA asked for?

You can, but you usually should not. Send what was requested, complete and organized, with a short explanation where context helps. Extra material can widen the review without helping you.

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.

OTC Drug GMP

Drug GMP under 21 CFR 210/211 for cosmetic and personal care makers moving into OTC products.

Form 483 and Warning Letter Response

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

Send us the request

Book a free 30-minute call, or call 858-240-4353 if a deadline is close. We will read the request with you and quote the same day.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting