1. Complaint Information
How Received:
Email
Phone
In-Person
Social Media
Other: __________
2. Product Information
3. Complaint Description
Type of Complaint:
Product quality (appearance, texture, odor)
Product performance
Skin reaction/irritation
Packaging issue
Labeling concern
Other: __________________
4. Severity Assessment
LOW
Minor quality issue
MEDIUM
Possible health concern
HIGH
Adverse reaction
MoCRA Requirement: Serious adverse events must be reported to FDA within 15 business days.
5. Investigation
Batch record reviewed
Retention sample examined
Raw material lots checked
Similar complaints checked
Production conditions reviewed
Product returned for inspection
6. Corrective Action
Customer Resolution:
Refund issued
Replacement sent
Explanation provided
No action (unfounded)
Other: __________
7. Follow-Up & Closure
Yes No N/A
Retention: Keep complaint records for at least 3 years. Review complaint trends periodically.