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. For professional regulatory guidance, please consult directly with a qualified expert.
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