How TESCON Helped a MedTech Manufacturer Lift a Permanent Injunction
Client: Mid-sized Medical Device Manufacturer
Challenge: Facing a permanent injunction and consent decree due to systemic QMS failures and a backlog of 50+ unresolved product failure modes.
The Challenge
A medical device manufacturer found themselves under a federal consent decree after repeated FDA inspections revealed critical gaps in their design controls, CAPA systems, and Medical Device Reporting (MDR) processes.
The FDA mandate required the company to:
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Cease production of non-essential lines.
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Retain an independent, third-party expert to oversee all remediation.
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Submit to rigorous, ongoing FDA oversight.
Overwhelmed, the client reached out to TESCON to navigate the complex remediation roadmap and regain regulatory standing.
The TESCON Approach: Strategic Remediation
TESCON stepped in as the independent partner to guide the client through the decree requirements with a focus on sustainable quality and compliance:
1. Objective Gap Analysis
TESCON performed a comprehensive audit against 21 CFR Part 820 and ISO 13485. By identifying the root causes of the 50+ failure modes, we moved the client beyond “band-aid” fixes to address systemic breakdowns at their source.
2. The Remediation Master Plan (RMP)
TESCON developed and executed a phased RMP, working in direct coordination with the FDA:
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Workflow Optimization: Redesigning CAPA and Change Control processes to ensure full, transparent auditability.
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Quality Culture Integration: Implementing competency-based training programs to ensure the client’s team lived and breathed “quality-first” decision-making.
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System Validation: Prioritizing the re-validation of critical manufacturing equipment and software to meet stringent regulatory requirements.
3. Transparent Regulatory Liaison
As the appointed third-party expert, TESCON acted as the primary bridge to the FDA. We ensured that every progress report was data-driven and met the agency’s exacting standards, helping to restore trust between the manufacturer and the regulators.
The Outcome
By partnering with TESCON, the client successfully achieved:
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Cleared Backlog: All high-risk failure modes were resolved within 18 months.
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Certification: Verification of compliance through a final, successful third-party certification audit.
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Operational Recovery: Resumed full manufacturing capacity following formal FDA notification of decree compliance.
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Long-Term Resilience: An institutionalized quality system that prevents the recurrence of regulatory warnings.