Mock FDA Inspections & Gap Assessment Services
Proactively Protect Your Business with Professional Mock FDA Inspections and Compliance Gap Assessments
Facing an FDA inspection can be one of the most stressful events for any manufacturer in the dietary supplement, food, pharmaceutical, medical device, or cosmetics industries. When FDA inspectors arrive, they don’t just glance at your paperwork—they systematically evaluate your entire quality system, your facility’s readiness, and your staff’s ability to demonstrate compliance with all applicable FDA regulations.
A real FDA inspection can last days or even weeks, uncovering even small procedural gaps that may lead to Form 483 observations, Warning Letters, import alerts, product seizures, lost contracts, and reputational harm that can take years to repair.
At FDAInspections.com, we help you avoid those risks with Mock FDA Inspections and Gap Assessments that simulate real FDA audits. Our expert consultants—including former FDA inspectors, regulatory professionals, and seasoned industry quality leaders—conduct rigorous, realistic, and industry-specific mock inspections designed to uncover weaknesses before FDA does.
We don’t just highlight problems. We help you understand them, fix them, and build a robust, audit-ready quality culture that meets FDA’s expectations and protects your business, your brand, and your customers.
Why Mock FDA Inspections and Gap Assessments Are Critical for FDA-Readiness
FDA inspections aren’t just a formality—they’re in-depth evaluations of whether your facility can consistently produce safe, compliant, high-quality products. Inspectors will demand:
Up-to-date, clear, enforced Standard Operating Procedures (SOPs)
Complete and accurate batch production records
Documented supplier qualifications and validated COAs
Robust, effective employee training with proof of competency
Validated cleaning and maintenance procedures
Well-documented deviation investigations and CAPA processes
For industries like dietary supplements, food processing, nutraceuticals, personal care, OTC drug manufacturing, sterile pharmaceutical production, and Class II/III medical device assembly, the stakes are even higher.
Even minor failures—like missing signatures, outdated SOPs, or untrained staff—can lead to FDA Form 483 observations, public Warning Letters, blocked imports, seized shipments, or the loss of vital retail partnerships and contract manufacturing deals.
Mock FDA Inspections and Gap Assessments give you a safe, private, expert-driven way to practice under “FDA-like” conditions, find and fix issues, and show your customers and partners you take compliance seriously.
Mock FDA Inspection Services We Offer
Realistic FDA-Style Facility Walkthroughs and Plant Assessments
We conduct thorough, realistic mock inspections that replicate how FDA inspectors evaluate facilities in nutraceutical production plants, dietary supplement contract manufacturers, beverage bottling facilities, pharmaceutical packaging lines, medical device cleanrooms, and food processing facilities.
Our expert consultants perform complete facility walkthroughs that include:
Entry briefings that mirror FDA’s formal approach
Systematic evaluation of production, packaging, labeling, storage, and QC areas
Close examination of cleaning and maintenance practices
Spot checks for labeling control, segregation, and material handling
Verification of physical condition and GMP cleanliness standards
We use FDA’s perspective to highlight deficiencies your team may overlook daily, delivering practical, prioritized findings you can act on immediately.
In-Depth Documentation and SOP Reviews
FDA inspectors don’t just check facilities—they demand proof your systems work.
We thoroughly review your:
SOPs for clarity, completeness, and up-to-date regulatory compliance (21 CFR Parts 111, 117, 210/211, 820)
Batch production records for accuracy and traceability, vital for dietary supplement GMP compliance
Cleaning logs and maintenance records for validated procedures
Supplier qualification files and Certificates of Analysis to prove identity and quality
Employee training records to confirm competency and documented refreshers
Deviation investigations and CAPA documentation to show continuous improvement
Our consultants flag missing data, inconsistencies, outdated SOP language, and incomplete training records—giving you a complete picture of documentation gaps FDA will notice.
Staff Readiness Assessments with Mock FDA Q&A
FDA investigators regularly ask line workers, supervisors, and QC staff tough questions to test real understanding:
“Who trained you to do this?”
“Show me the SOP you follow.”
“How do you clean this equipment between batches?”
“What do you do if you find something wrong?”
“What is your role in approving production records?”
Our Mock Q&A sessions simulate these interactions in a supportive, learning-focused environment.
We test staff at every level—from packaging line workers in nutraceutical facilities to lab technicians in pharmaceutical QC labs to warehouse managers handling regulated ingredients.
After the session, we deliver detailed feedback, coaching your team on:
Avoiding contradictory or incomplete answers
Citing SOPs and records correctly
Staying calm under pressure
Understanding and owning their compliance responsibilities
These sessions help build real confidence and consistent messaging across all shifts and roles.
Detailed Written Gap Assessment Reports
We don’t just tell you “fix everything.”
You receive a detailed, prioritized written report with:
Specific observations noted during the mock inspection
Document control weaknesses and missing records
SOP gaps or noncompliant practices
Staff training needs and knowledge inconsistencies
Facility maintenance and GMP cleanliness observations
Systemic weaknesses that could lead to repeat FDA findings
For each gap, we provide actionable recommendations, realistic timelines, and practical implementation tips so you can build a roadmap to inspection readiness.
Corrective Action and Preventive Action (CAPA) Planning Support
FDA expects robust CAPA systems that don’t just fix one batch—they prevent problems from recurring.
After your gap assessment, we help you:
Conduct root cause analyses that go beyond blaming individual error
Draft CAPA plans with clear corrective steps and system-wide preventive measures
Define timelines, responsible personnel, and verification strategies
Build training updates to reinforce process improvements
Create audit trails and evidence to prove effectiveness to FDA
Our CAPA planning support ensures your remediation efforts satisfy FDA expectations and strengthen your entire quality system.
FAQ’s
What is a Mock FDA Inspection and Gap Assessment?
It’s a realistic, expert-led simulation of a real FDA inspection that identifies gaps in your facility, documentation, SOPs, and staff readiness—so you can fix them before FDA’s real inspection.
Why do supplement manufacturers need mock FDA inspections?
Because dietary supplement GMP (21 CFR Part 111) is strict. Even small gaps in SOPs, testing, cleaning logs, or training can trigger FDA 483 observations. A mock inspection finds these gaps so you can correct them proactively.
How do food and beverage producers benefit from gap assessments?
Food processing facilities under 21 CFR Part 117 need complete documentation, cleaning validation, and supplier controls. Gap assessments identify weaknesses in preventive controls and hazard analyses before FDA finds them.
Can pharma and medical device companies use mock FDA inspections?
Absolutely. Pharmaceutical manufacturers (21 CFR Parts 210/211) and medical device firms (21 CFR Part 820) face intense FDA scrutiny. Mock inspections test your QMS, SOP adherence, and batch record completeness to avoid serious regulatory action.
Do you help us fix the issues you find?
Yes. We don’t just identify gaps—we help you plan effective CAPA, revise SOPs, train staff, and prepare for FDA’s follow-up inspections.
Who We Help
Our Mock FDA Inspections and Gap Assessments are perfect for:
Dietary Supplement Manufacturers and Nutraceutical Brands
Food and Beverage Producers and Bottling Facilities
OTC Drug Manufacturers and Pharmaceutical Packaging Plants
Medical Device Assemblers and Cleanroom Facilities
Cosmetics and Personal Care Product Manufacturers
Importers, Private Label Brands, and Contract Manufacturers
We tailor our approach to your industry, product type, and regulatory requirements—so you get practical, relevant, and effective preparation.
Why Choose FDAInspections.com?
Expert-Led: Our team includes former FDA inspectors and industry quality leaders.
Industry-Specific: We understand the nuances of supplement, food, pharma, medical device, and cosmetics manufacturing.
Realistic, Honest Feedback: We won’t sugarcoat gaps—we’ll help you fix them.
Detailed Reporting: Actionable, prioritized recommendations your team can implement immediately.
End-to-End Support: From assessment to CAPA planning, SOP updates, staff training, and follow-up readiness.
Our mission is simple: Help you avoid regulatory surprises and build a culture of compliance that lasts.
Ready to Discover and Fix Your Compliance Gaps Before FDA Does?
Don’t wait for an FDA inspector to find the gaps in your systems. Be proactive. Be prepared. Be confident.
FDAInspections.com delivers Mock FDA Inspections and Gap Assessments that find and fix weaknesses before they threaten your business.
Contact us today to schedule your assessment and take the first step toward truly being FDA inspection-ready.