FDA Inspection Readiness

Walk into your next FDA inspection calm, prepared, and in control

BioBoston Consulting helps life science teams identify gaps before the FDA does. Former FDA investigators and senior QA leaders run a realistic mock inspection, deliver a clear readiness plan, and help your team perform with confidence.

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Former FDA investigators available
Fast kickoff (often within 2 weeks)
Pharma, biotech, and medical device experience
On-site or remote support

Who this is for

This service is a fit if

You have an FDA inspection expected in the next 30–120 days
You recently received a 483 / Warning Letter, or want to prevent one
You’ve had rapid growth, tech transfer, or new leadership and want alignment
Your SOPs, records, or training feel inconsistent across teams or sites
You want your team to answer questions clearly without over-explaining or freezing

What you’ll get

You will receive a practical, inspection-ready package:
Mock inspection plan (scope, agenda, interviews, and sampling approach)
On-site or remote mock inspection led by a former FDA investigator or senior QA lead
Clear gap list prioritized by risk (what matters most to FDA)
Executive summary your leadership team can act on quickly
CAPA and remediation recommendations with “next 30/60/90 days” guidance
Optional: Inspection day “war room” support and rapid-response coaching

What we do

Our FDA Inspection Readiness support can include:

Full-scale mock inspection and gap assessment
SOP and record review (training, deviations, CAPA, change control, complaints, supplier quality, etc.)
Inspection-ready document organization and retrieval practice
Role-based interview training (SMEs, QA, leadership)
On-site support during inspection (as allowed) and daily debriefs
Post-inspection remediation support (CAPA execution, evidence, effectiveness checks)

Why BioBoston

Senior expertise that reduces risk, fast.
Former FDA investigators and experienced industry QA leaders
We simulate the real inspection experience (interviews, sampling, pressure points)
We focus on what FDA actually cares about: evidence, consistency, and control
We don’t stop at findings—we help you fix the root causes and close them
Recent examples of how we help:
Helped a fast-growing biotech prepare for an FDA inspection by running a mock inspection, aligning documentation, and coaching SMEs on interview responses to reduce inspection-day surprises.
Supported a manufacturer after quality system changes by identifying high-risk gaps and guiding CAPA execution and evidence collection to strengthen inspection readiness.