Clarity. Compliance. Confidence.
Audit Readiness Tool
Are You Inspection Ready?
An FDA inspection isn't a matter of if — it's when. Walk through each section, check off what's in place. Every unchecked item is a gap that could become a finding. Built for tobacco, e-cigarette, and nicotine product manufacturers.
1
Registration & Product Listing
5 items▸
✓
Establishment is registered with FDA and current (renewed annually by Dec 31)
Critical
✓
All commercially marketed products are listed with FDA
Critical
✓
Product listings are accurate and up to date (ingredients, quantities, names)
High
✓
Registration and listing confirmation records are accessible on-site
High
✓
Any new products since last update have been submitted
High
2
Premarket Authorization
5 items▸
✓
All products have required premarket authorization (PMTA, SE, or Exemption)
Critical
✓
Marketing orders or authorization letters are on file and accessible
Critical
✓
No products are marketed beyond the scope of their authorization
High
✓
Products under pending review have documentation of timely submission
High
✓
Modified products have been evaluated for whether a new submission is required
High
3
Quality Management System
7 items▸
✓
Written quality policy and quality manual exist and are current
Critical
✓
Organizational chart with quality responsibilities is documented
High
✓
Management review of the QMS is conducted at defined intervals with records
High
✓
Internal audits are scheduled and conducted with documented findings and CAPAs
Critical
✓
Supplier qualification program is in place with approved supplier list
High
✓
Incoming material inspection/testing procedures exist and are followed
High
✓
Nonconforming product procedures are documented with records maintained
Critical
4
Document & Record Control
6 items▸
✓
Document control procedure exists (creation, review, approval, distribution)
Critical
✓
All SOPs are current, approved, and accessible to relevant personnel
Critical
✓
Obsolete documents are removed from use and archived
Critical
✓
Records retention policy meets FDA requirements (min 4 years for most tobacco records)
High
✓
Electronic records comply with 21 CFR Part 11 if applicable
High
✓
Batch/production records are complete, legible, and traceable
Critical
5
Manufacturing & Process Controls
8 items▸
✓
Manufacturing processes are documented with step-by-step procedures
Critical
✓
In-process controls and checkpoints are defined and recorded
High
✓
Equipment is calibrated on schedule with records maintained
High
✓
Facility is clean, organized, and free of contamination risks
High
✓
Pest control program is in place with monitoring records
High
✓
Ingredient and component specifications are documented
High
✓
Finished product specifications and testing procedures are in place
High
✓
Change control procedure exists for process, equipment, or formulation changes
High
6
Labeling & Packaging
6 items▸
✓
Required health warnings are present, properly formatted, and rotated per FDA
Critical
✓
Net quantity of contents is accurately stated
High
✓
No modified risk claims without FDA authorization ("safer," "less harmful")
Critical
✓
Labels do not contain false or misleading information
High
✓
Labeling control procedures prevent mix-ups during packaging
High
✓
Promotional materials and advertising comply with FDA marketing restrictions
High
7
Adverse Experience & Safety Reporting
4 items▸
✓
Procedure for collecting and evaluating adverse experience reports is in place
Critical
✓
Serious and unexpected adverse experiences are reported within required timeframes
Critical
✓
Records of all adverse experience reports are maintained and accessible
High
✓
Staff knows how to identify and escalate potential adverse events
High
8
Training & Personnel
5 items▸
✓
Training program exists for all personnel in manufacturing and quality
Critical
✓
Training records are current (date, topic, trainer, trainee acknowledgment)
Critical
✓
Personnel are trained on their specific SOPs and job functions
High
✓
GMP / regulatory awareness training is conducted and documented
High
✓
New hire training is completed before independent work begins
High
9
CAPA & Complaint Handling
5 items▸
✓
All open CAPAs have assigned owners and target dates
Critical
✓
Root cause analyses are documented and defensible
High
✓
Complaints are logged, investigated, and resolved with documented records
Critical
✓
Effectiveness checks completed for closed CAPAs
High
✓
Trend analysis of complaints and nonconformances is performed periodically
High
10
Inspection Day Readiness
7 items▸
✓
Designated point of contact for FDA inspectors is identified and trained
Critical
✓
Front desk / reception knows to notify management immediately when FDA arrives
High
✓
Inspection room is prepared and stocked
High
✓
Key personnel are briefed on protocols (answer only what's asked)
Critical
✓
Prior 483s and EIRs reviewed — all commitments completed
Critical
✓
Corrective actions from prior inspections are documented and verified effective
High
✓
Critical records can be retrieved quickly (registration, batch records, training, CAPAs)
High
Get your readiness score.
See how your compliance program stacks up.
Disclaimer: This checklist is provided for general informational and educational purposes only. It does not constitute legal, regulatory, or compliance advice. Results are based solely on user-provided responses and do not represent an official audit, assessment, or certification. QualReg Solutions assumes no liability for decisions made based on these results.
Clarity. Compliance. Confidence.
© 2026 QualReg Solutions, LLC