Mock FDA Audits & Gap Assessments

Cerulean’s mock FDA audit is your best defense against compliance breakdown, warning letters & FDA-483s

Cerulean’s mock FDA inspection and gap analysis for QSR, cGMP, Part 11, ICH or IMDRF compliance has been developed specifically for small to midsized businesses and single site divisions.


  • Objective assessment of compliance
  • Detailed gap analysis with straightforward explanations
  • Prioritized set of recommendations tailored to your business
  • Your choice of a concise, quick-action summary report or a detailed, lengthy report and binder
  • Appendices with suggested fixes, templates & forms you can use or expand upon
  • Iterative drafts of the audit report to incorporate your feedback
  • Independent audit certificate
  • Demonstrated proof of continual improvement
  • Staff coaching on regulatory inspection methodology, types of questions, and how best to prepare
  • 30 days of free post-report follow-up advice

Plus one full year of free help preparing for any regulatory inspection or third-party audit.

Use for

  • FDA, EMA or Health Canada inspection preparation
  • ISO certification preparation
  • Pre-approval inspection (PAI/PMA) readiness
  • Proof of management oversight
  • An assessment of your records & document controls
  • Qualifying critical suppliers
  • Assessing 21 CFR 11 cost-effectiveness
  • A baseline for future improvements and self-audits
  • Verification your quality management or regulatory affairs teams are on the right track
  • Records control reviews
  • Contract service provider reviews – especially data integrity compliance for IT outsourcing
  • Process controls evaluations
  • Identification of operational improvements for the upcoming year
  • Proof of compliance for prospective business partners & customers

Sample Downloads

More Resources

  • Recorded seminar & resource kit:  Bulletproof Yourself against FDA Enforcement

Call +1 757 645 2864 or email us. We offer a free half hour consultation to new clients

What’s Covered

  • Organization capability, experience & environment
  • Policies, SOPs, forms and work flows
  • Records and information management
  • Management controls & reviews
  • Change control and management
  • Internal audit program
  • Corrective and preventative action (CAPA)
  • Training
  • Quality unit & regulatory affairs responsibilities
  • Purchasing controls
  • Supplier quality management
  • Record integrity controls
  • Facility operations, warehousing & shipping
  • Physical security
  • Quality by design incorporation
  • Processing, sterilization & calibration
  • Validation and qualification
  • Computer system compliance (Part 11 & Annex 11)
  • Electronic data security and data integrity controls
  • Laboratory & clinical oversight (as appropriate)
  • ICH compliance (as appropriate)
  • IMDRF/GHTF compliance (as appropriate)
  • ISO compliance (as appropriate)

And throughout, we’ll provide you clear-cut, practical answers on what’s required versus what’s a “nice-to-have.” Download a sample mock FDA audit schedule.

Most audits are done by one auditor, although additional auditors – former FDA employees and industry specialists – are brought in as required. The typical audit includes some level of remote review of SOPs and policies to better focus on the onsite work, lasts between 2-3 days per site, and then relies upon an additional 20-30 days to draft the initial report and detailed recommendations, review the report with you, incorporate your feedback, and then finalize and submit the report.

Cerulean’s mock FDA audit clients receive one full year (12 months) of free help in the event of a regulatory inspection, a complete fee refund in the event we don’t meet our agreements with you, and much more.  Learn about our industry-unique triple guarantee or see our preliminary cost range for a mock FDA audit.