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.
- 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
Readiness plan + scope
We propose the right scope (mock inspection, gap assessment, training) and assign the best former FDA investigator or senior lead
Execute + stabilize
We run the mock inspection, deliver prioritized findings, and support remediation so your team is ready
30-minute intake
You share your inspection timing, product type, sites, and top concerns
How it works
Frequently Asked Questions
Often within 1–2 weeks depending on scope and site logistics.
Yes. We match the right lead based on your product type and history (GMP/QSR, combination products, etc.).
Yes. Many clients engage us for 4–12 weeks after the mock inspection to execute CAPAs and build lasting readiness.