Rapid Triage, Corrective Actions & Submission-Ready Responses
We help companies respond to FDA warning letters with structured corrective action plans, documentation remediation, and defensible regulatory strategies that address root causes—not just surface-level compliance theater.
Why Warning Letters Require Immediate, Strategic Action
A warning letter isn't just a compliance issue—it's a public signal of serious regulatory concern. The 15-business-day response deadline is real, and inadequate responses trigger consent decrees, import alerts, injunctions, and loss of customer confidence.
- Public disclosure: Warning letters are posted online—customers, partners, and competitors will see it.
- Regulatory escalation: Inadequate responses lead to consent decrees, seizures, injunctions, or debarment proceedings.
- Business impact: Major retailers, distributors, and contract partners may pause orders or terminate relationships.
- Root cause requirement: FDA wants systemic fixes, not cosmetic corrections or vague commitments.
Warning Letter Response Programs
Structured triage, corrective action development, and submission-ready documentation—fast.
48-Hour Emergency Triage
Typical range: $3,500–$6,500
For companies that need immediate analysis of citations, risk assessment, and a sequenced response roadmap.
- Citation-by-citation breakdown with severity classification
- Gap analysis: what's missing vs. what FDA expects
- Response timeline + task assignment framework
- Quick-win vs. long-term CAPA identification
Complete Response Development
Typical range: $18,000–$45,000
For companies that need a complete, submission-ready response with corrective actions, documentation, and evidence packages.
- Corrective action plan (CAPA) development for each citation
- Documentation remediation (SOPs, records, validation protocols)
- Response letter drafting (executive summary + detailed actions)
- Evidence compilation and submission formatting
CAPA Implementation & Documentation
Typical range: $12,000–$35,000
For companies that need help executing corrective actions, updating systems, and building defensible documentation trails.
- SOP creation or revision (manufacturing, QC, complaint handling, etc.)
- Training program development and documentation
- Quality system enhancement (deviations, CAPAs, change control)
- Mock audit preparation with gap closure verification
Reinspection Readiness Program
Typical range: $15,000–$40,000
For companies preparing for follow-up FDA inspection to demonstrate corrective action effectiveness.
- Mock inspection with citation-focused review
- Documentation package audit (traceability, completeness, consistency)
- Staff interview preparation and regulatory communication training
- Final gap closure verification before FDA returns
Common Warning Letter Citations We Address
CGMP Violations (21 CFR 211)
Manufacturing controls, component testing, process validation, equipment qualification, cleaning validation, expiry dating.
Quality System Failures (21 CFR 820)
Design controls, CAPA effectiveness, complaint handling, corrective/preventive action documentation for devices.
Misbranding & Labeling (21 USC 352)
Unapproved drug claims, false or misleading statements, inadequate directions for use, unsubstantiated structure/function claims.
Adulteration (21 USC 351)
Insanitary conditions, lack of process validation, contamination risks, failure to follow written procedures.
Advertising & Promotion
Off-label promotion, omission of risk information, misleading efficacy claims, unbalanced presentations.
Data Integrity Issues
Record falsification, audit trail gaps, electronic record/signature compliance (21 CFR Part 11), raw data discrepancies.
How We Structure Warning Letter Responses
Rapid assessment, root cause identification, defensible corrective actions, and submission-ready documentation.
Citation Analysis & Risk Assessment
We break down each citation, classify severity, identify systemic vs. isolated issues, and map required corrective actions.
CAPA Development
We design corrective and preventive actions that address root causes, include verification methods, and demonstrate sustainability.
Documentation & Implementation
We create or revise SOPs, validation protocols, training records, and quality system documents to support the CAPA plan.
Response Letter & Evidence Package
We draft the formal response letter, compile supporting evidence, and format the submission for clarity and defensibility.
Who Needs Warning Letter Response Support
Drug & OTC Manufacturers
Companies facing CGMP citations, process validation gaps, or quality system failures that need rapid corrective action.
Medical Device Companies
Firms with 21 CFR 820 citations related to design controls, CAPA, complaint handling, or production/process controls.
Dietary Supplement Brands
Brands cited for structure/function claims, CGMP failures, or misbranding that need to preserve market access while fixing issues.
Cosmetic Companies
Companies with insanitary conditions, misbranding, or unapproved drug claims that shifted their product into FDA's enforcement zone.
Contract Manufacturers
CMOs that need to respond quickly to protect client relationships and prevent business interruption from regulatory action.
Importers & Distributors
Companies responsible for products cited at entry or through post-market surveillance that need clear responsibility boundaries.
Warning Letter FAQs
How quickly can you start after we receive a warning letter?
We can typically begin triage within 24 hours of engagement. Our 48-hour emergency triage delivers a citation breakdown, risk assessment, and response roadmap so you can start corrective actions immediately.
What if we can't fix everything within 15 business days?
FDA understands that some corrective actions take time. The key is demonstrating that you've identified root causes, initiated meaningful corrective actions, and committed to specific timelines with interim milestones. We help structure responses that acknowledge complexity while showing serious commitment.
Can you work with our internal quality team or legal counsel?
Yes—we often collaborate with in-house quality, regulatory, and legal teams. We provide the regulatory strategy and technical documentation support while your team maintains final decision authority and attorney-client privilege where applicable.
What happens if FDA finds our response inadequate?
If FDA issues a follow-up letter indicating deficiencies in your response, we can provide additional corrective action development, enhanced documentation, and more detailed evidence to address their concerns. The goal is always to avoid escalation to consent decrees or other enforcement actions.
Are these pricing ranges fixed?
No—these are estimated ranges based on typical engagements. Every warning letter situation is unique, involving different numbers of citations, facility types, product categories, and quality system complexities. After reviewing your specific warning letter and understanding the full scope of required corrective actions, we provide a detailed flat-rate quote tailored to your situation. Complex, multi-site situations or consent decree work may exceed these ranges.