Client Business Situation
A leading high-volume manufacturer of consumer medical devices located outside of the United States was experiencing increased concern regarding their regulatory compliance enforcement profile. Factors contributing to this increasing concern included strong enforcement actions at a sister division and known deficiencies in multiple aspects of the company’s quality systems identified through internal audits and a mock FDA inspection.
Client Business Pain
Client was exposed to significant risk of import cessation of over $250 million dollars of product on an annualized basis due to increased enforcement activity and potential for the FDA to conduct an inspection of the facility within months.
Solutions Provided/Services Delivered
Compliance Architects® provided a Senior Consultant with extensive subject matter expertise in FDA inspection readiness. Activities performed for this client included (but was not limited to):
- Revision of client’s remediation task list into project-oriented 30 day plan with program management framework to ensure completion of activities on time;
- Management of revised remediation program to achieve remediation objectives;
- Development of enforcement history commitments’ matrix outlining historical regulatory commitments and documenting actions and documents responsive to commitments made;
- Drafting and implementation of major revisions to CAPA and Validation procedures/systems;
- Training of company Subject Matter Experts on inspection conduct and preparation;
- Drafting and coordination of inspection readiness action plan to ensure company readiness prior to notified inspection date.
Following a full week’s FDA inspection six months after Compliance Architects® arrived onsite, the client received no Form 483 resulting from the inspection. The client’s supply situation was stabilized preserving over $250 million dollars in annualized revenue.
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