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 GLP, GCP, GMP, QSR, Part 11, ICH or IMDRF compliance has been developed specifically for small to midsized businesses and single site locations.


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

Use for

Sample Downloads

Email Cerulean today. We offer a free half hour consultation to new clients

What’s Covered

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 remote 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.