Resolve Quality Issues, Prevent Recurrence, and Maintain Regulatory Compliance

Turn Compliance Challenges Into Continuous Improvement

An effective CAPA program is a cornerstone of a robust Quality Management System. At J&J CC Group, we help manufacturers design and implement smart, scalable, and compliant Corrective and Preventive Action programs that not only meet FDA and ISO requirements—but actually improve operations.

Whether you’re dealing with non-conformances, customer complaints, audit findings, or FDA 483 observations, our CAPA consultants help you investigate root causes, implement sustainable fixes, and prevent future issues—reducing risk and protecting your brand.

Why a Strong CAPA System Matters

⚠️ FDA’s #1 Inspection Finding: CAPA is consistently one of the most cited issues during FDA inspections (21 CFR 820.100).
🔍 Global Expectations: ISO 13485, EU MDR, and other regulators require documented CAPA systems.
💡 Business Impact: Ineffective CAPAs can lead to recalls, loss of certification, or production downtime.

Our CAPA Consulting Services Include:

🔹 CAPA Program Design & Implementation

• Build or overhaul your CAPA process to meet FDA, ISO, and EU MDR standards

• Customized workflows for investigation, documentation, and closure

• Integration with existing QMS and electronic systems

🔹 Root Cause Analysis (RCA) Facilitation

• Use of proven RCA tools: 5 Whys, Fishbone, Fault Tree Analysis, and more

• Data-driven problem-solving methodology

• Cross-functional RCA team training

🔹 CAPA Remediation & Backlog Reduction

• Support for resolving open or overdue CAPAs

• Assistance with CAPA responses to FDA 483s, Warning Letters, or audit findings

• Documentation alignment with regulatory expectations

🔹 Training & Program Audits

• Hands-on CAPA training for quality, manufacturing, and leadership teams

• Internal audit of CAPA effectiveness

• Readiness for FDA inspections and third-party audits

Industries We Serve

• Medical Devices (Class I–III, SaMD, diagnostics)

• Pharmaceutical & Biotech

• Nutraceuticals & Dietary Supplements

• Food & Beverage Manufacturing

• Advanced Manufacturing & Contract Manufacturers

Why Clients Choose J&J CC Group

✅ Consultants with FDA, ISO, and industry backgrounds
✅ Results-driven approach focused on effectiveness, not just compliance
✅ Templates, tools, and workflows tailored to your company’s size and structure
✅ Proven success with FDA inspection readiness and audit recovery

Build a CAPA Program That Drives Improvement, Not Just Paperwork

Stop chasing symptoms. Start fixing root causes. Our CAPA experts help you reduce recurring issues, improve product quality, and ensure your systems stand up to regulatory scrutiny.

📞 Book a Free Consultation Today
Let’s assess your CAPA program and help you take corrective action with confidence.