Ensuring Compliance at a Nutritional Health Manufacturer

Client Context

A global leader in the development, manufacturing, and commercialization of science-based nutritional health products faced critical process and infrastructure flaws at one of its European factories.

With 7 manufacturing sites, 13 brands, and over 1,300 employees worldwide, the company was struggling to maintain compliance with internal corporate and public administration standards. At the same time, rising customer demand exposed additional weaknesses in production and packaging operations, leading to frequent production stoppages.

The urgency of these issues escalated as the company’s controlling private equity firm prepared for an imminent sale to a major industrial conglomerate, making the mitigation of compliance risks a prerequisite for the transaction.

Key Challenges

• Obsolete ventilation systems, preventing compliance with air flow and cleaning regulations.
• Ineffective emergency response procedures, creating health, safety, and operational risks.
• Explosion risk due to inadequate infrastructure and monitoring.
• 60 deviations from Good Manufacturing Practices (GMP) identified by a public health & safety audit, threatening production continuity.
• Limited resources and lack of proactive decision-making, with projects running parallel to other ongoing initiatives.

Approach & Key Success Factors

EFESO collaborated with global and local operations teams to rapidly address compliance risks through four simultaneous workstreams:

1. Ventilation System Compliance

• Identified regulatory barriers preventing further upgrades to the obsolete ventilation system.
• Developed a replacement strategy to meet compliance requirements and ensure proper air flow and cleaning.

2. Emergency Response & Safety Procedures

• Strengthened Health, Safety, and Emergency (HSE) policies and procedures.
• Implemented 24/7 operational emergency response measures to safeguard employee well-being.

3. Explosion Risk Mitigation

• Conducted a comprehensive safety audit of infrastructure and procedures.
• Designed and implemented risk monitoring and compliance protocols.

4. GMP Compliance & Audit Resolution

• Addressed 60 GMP deviations identified in the public health & safety audit.
• Developed a structured plan to resolve non-compliance issues within six months, ensuring production continuity.

Results

Eliminated compliance violations

Achieving full adherence to HSE and GMP requirements.

Enabled the successful sale

Of the company to a major industrial conglomerate.