FDA Inspection Services
FDA Inspection Services Built by Former FDA Investigators
Former FDA investigators help regulated companies prepare for inspections, respond to observations, and keep quality systems ready for review.
Inspection readiness and response support
Core Services
FDA Compliance and Inspection Services
Get focused help before, during, and after FDA inspection activity, with service paths built around records, people, facilities, corrective actions, and follow-up evidence.
Inspection Readiness Audits
Former FDA investigators review facilities, records, quality systems, and staff readiness before FDA arrives.
- Gap assessments
- Facility walkthroughs
- Readiness reports
Mock FDA Inspections
Teams practice FDA-style interviews, document requests, facility walkthroughs, and closeout preparation.
- Interview prep
- Document requests
- Closeout coaching
FDA 483 Response Support
Turn observations into root cause analysis, CAPA plans, written responses, timelines, and evidence packages.
- Root cause review
- CAPA planning
- Response drafting
Warning Letter Remediation
Build response plans, corrective actions, progress evidence, and preparation for FDA follow-up.
- Remediation plans
- Evidence packages
- Follow-up readiness
GMP Gap Analysis
Review procedures, batch records, supplier controls, deviations, complaints, training, and quality oversight.
- cGMP checks
- Quality records
- Gap report
On-Site Inspection Support
Support inspection-room work, daily debriefs, document flow, request tracking, and response planning.
- Inspection room setup
- Daily support
- Request tracking
Staff Training
Prepare QA, QC, production, regulatory, and leadership teams for FDA questions and inspection conduct.
- Inspection conduct
- Role-based training
- Interview practice
Virtual FDA Consulting
Remote help for document review, mock interviews, CAPA review, and inspection readiness planning.
- Virtual reviews
- Remote interviews
- Action planning
Why Work With Us
Inspection Support Built Around FDA Expectations
Our consultants focus on the inspection moments that matter most: how records are requested, how staff answer questions, and how corrective actions are documented.
Former FDA Investigators
Work with consultants who know how FDA inspection teams ask questions, request records, and read quality evidence.
Learn MorePractical CAPA Support
Connect observations to root cause work, corrective actions, owners, dates, and proof of completion.
Learn MoreIndustry-Specific Readiness
Support pharmaceutical, device, biologics, cosmetic, supplement, food, and animal health teams.
Learn MoreOn-Site and Virtual Options
Choose focused remote reviews, full mock inspections, on-site help, or post-inspection response work.
Learn MoreCommon Questions
Frequently Asked Questions
Services include mock FDA inspections, inspection readiness audits, FDA 483 response help, Warning Letter remediation, GMP gap analysis, staff training, and virtual consulting.
Yes. Teams can review records, run mock interviews, test facility walkthroughs, and close gaps before FDA arrives.
Yes. Consultants can help with root cause analysis, CAPA plans, response drafting, progress evidence, and preparation for FDA follow-up.
Yes. Some projects work well by video and document review. Facility walkthroughs, mock inspections, and inspection-room support can be handled on site.
