FDA Warning Letter?
Get Your Complete Response Plan in 7 Days - Guaranteed.
Respond. Remediate. Defend.
Your complete FDA Warning Letter response system. Built, deployed and defended in just 7 days.
Instant access. Full support. No guesswork.
3 Outstanding Benefits of our Remediation Program
Tailored FDA Response Letter and Quality Remediation Plan in just 7 days.
All the document templates you need for an audit ready Quality System.
Expert support through the program to rapidly increase compliance.
Who This is Program For?
Our 7-Day Rapid Response Remediation Program can help if this is you:
The Problem
Sites that have received a recent FDA Warning Letter and require a rapid response and remediation plan.
The Person
Quality Directors, Compliance Leads, and Site Heads that want to take a proactive remediation approach.
The Timeline
Sites that are under 90-day remediation timelines and need to respond to FDA Warning Letters.
The Modality
Sterile, Non-sterile, ATMP, or High-Risk API facilities that received an FDA Warning Letter.
The Bandwidth
Teams committed to quality but lacking bandwidth and needing compliant and audit-ready results fast.
What You Get – Day 1 Access
Everything you need to respond with confidence, avoid escalation, and pass inspection:
FDA Response Pack
Complete, structured response letter with root cause tools and CAPA tracker. Built to FDA expectations. Saves time, avoids escalation, and puts you in control from Day 1.
FDA-Compliant Quality Updates
​SOPs, policies, protocols, validation templates, and QMS links. All pre-formatted, Annex 1 and Part 211 aligned. Removes ambiguity and ensures your system can withstand regulatory scrutiny.
Expert Support (All 7 Days)
Direct access to Pharmalliance GMP specialists by email and video. Includes Day 1 kickoff, daily check-ins, and optional 1:1 review to guide your team through execution.
Risk Assessment Toolkit
​Rapid tools to identify, prioritise and map GMP and contamination risks. Includes facility flow maps, risk matrices, and cleanroom failure libraries to get instant visibility and action alignment.
Contamination Control Strategy
Pre-built CCS framework covering cleaning, EM, gowning and smoke studies. Integrates directly into your PQS and includes validation, integration and training materials to meet Annex 1 expectations.
Audit-Ready Documentation
​Instant access to SOPs, dashboards, walkthrough decks, and inspection Q&A binders. Every tool formatted for inspection use — no guesswork, just results you can present confidently.
Corporate Quality Plan
Fully developed remediation roadmap linked to CAPAs, timelines, owners and QA sign-off. Structured for executive review and ready for submission to regulators within 7 days.
CPD-Certified Training Program
Ready-to-deploy GMP and contamination control modules for QA, operators, and engineers. SCORM-compatible and audit-ready with assessments, training matrix, and certification for inspection evidence.
Bonus Compliance Tools
​Includes 30+ SOPs, FDA 483 examples, audit checklists, risk assessments, 100 licenses for CPD training, and CCS templates. Value of €50k — all included with your site license at no extra cost.
7-Day Execution Plan — One Clear Deliverable Per Day
FDA Response Pack
You Get:
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FDA Response Letter Template (regulatory language + CAPA structure)
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Root Cause Analysis Tools: 5-Why, Fishbone, Human Error
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CAPA Tracker (with risk ranking, owners & due dates)
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Executive Brief: “What This Means” deck for internal alignment
Contamination Control Strategy
You Get:
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CCS Master Template (PDA/ECA aligned)
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Cleanroom Behaviour, Gowning, Cleaning SOPs
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Smoke Study Protocol & Report Format
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HEPA, Flow and Cleaning Validation Protocol Builder
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CCS-QMS Integration Map
Risk Identification / Gap Analysis
You Get:
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Facility Risk Map (people, product, air, waste)
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GxP Process Criticality Matrix
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Part 211 and Annex 1 Gap Mapper
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Environmental Monitoring and Utilities Risk Tools
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FMEA Templates (pre-populated for cleanrooms and equipment)
Training & Behaviour Change
You Get:
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CPD-Certified Training: GMP Fundamentals, Contamination Control Excellence Program
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35 Microlearning Modules (24/7, online and SCORM-ready)
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Training Matrix + Role-Based Modules
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Operator Training Assessments + Audit-Ready Records
Corporate Remediation Plan
You Get:
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Corporate-Level Remediation Strategy (FDA audit-proof format)
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SOP Gap Identifier Tool (auto cross-check vs regs)
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Risk-Based Implementation Plan (linked to CAPAs) ready for FDA submission
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RACI Matrix for Quality, Engineering, Operations
Inspection Readiness Pack
You Get:
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Finalised Response Letter + Supporting Documents
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Inspection Walkthrough Deck (10-slide format)
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​FDA 483 Reference Binder (with model answers)
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SOP-to-Reg Clause Mapping Tool
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Mock Inspection Readiness Checklist
Testimonials
QA Lead, Sterile Operation
“Pharmalliance delivered exactly what we needed – fast, relevant, and high-quality Aseptic Fundamental training tailored to our sterile ophthalmic remediation project. "
Executive Project Lead, OSD
"Their team’s real-time oversight and deep compliance knowledge were critical in improving documentation (ALCOA) and reducing deviations and aligning us with EU GMP expectations."
QA Manager, Sterile OTC
“We faced numerous technical challenges, but their service delivered brilliant solutions. Their hands-on approach meant we felt supported throughout the project. ”
Included Bonuses
1
Internal Audit Toolkit
We provide all the templates that you need to identify your cGMP / Annex 1, and Microbial Control risks. These risks are assigned a Risk Priority Number (RPN) and linked to CAPA's.
2
CPD Training Modules
Our CPD Certified cGMP Fundamental and Contamination Control Program elevate your sites knowledge and compliance level quickly. These training programs are available 24/7.
3
Full Site Access
Remediation should not be confined to a select few individuals. For lasting change the whole site gets access to our CPD Certified material for 1 year post purchase.
Some of our happy clients
