What's in your 5-document package:
1
FDA WL Response Letter
Formal response acknowledging observations. Submit within 15 business days.
2
CAPA Plan
Full Corrective and Preventive Action plan per 21 CFR §820.100 / ICH Q10
3
Root Cause Analysis
5-Why + Fishbone worksheet. FDA expects documented, evidence-based RCA.
4
Compliance Checklist
Regulation-specific audit checklist for the cited 21 CFR section
5
FDA Meeting Request Letter
Optional teleconference request template for complex situations
Supported FDA-regulated sectors:
🔬 Medical Devices (21 CFR 820)
💊 Pharmaceuticals (21 CFR 210–211)
🥗 Food / FSMA (21 CFR 110/117)
💄 Cosmetics (21 CFR 700)
🧬 Biologics (21 CFR 600)
Common CFR citations covered: 820.100 (CAPA), 820.30 (Design Controls), 211.22 (QC Unit), 211.113 (Microbial Control), 211.160 (Lab Controls), 117.135 (FSMA Preventive Controls), 820.198 (Complaint Files), 820.75 (Process Validation) and 40+ more
Pricing
Pay per package. No subscription required.
Single Package
$229.99 /package
1 FDA Warning Letter CAPA Response Package (5-doc ZIP)
SAVE 20%
3-Package Bundle
$549.99 ($183/pkg)
3 FDA Warning Letter packages — ideal for multi-product firms or consultants
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RA Consultant Monthly
$999 /month
10 packages/month for RA consultants and regulatory affairs firms
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5 DOCX documents + README — ZIP download ready
⬇️ Download ZIP PackageReview all documents with your RA counsel before FDA submission.