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APAC FDA Consulting Services & Solutions
Mock FDA Inspections & Audits
We at APAC FDA Consulting understand that preparing for a real FDA inspection or audit can be a detailed, time consuming, and stressful task. Many companies worry about potential fines, penalties, or even product recalls if they fail to comply with FDA regulations.
That’s why we offer comprehensive mock FDA inspection services to help you prepare for an actual FDA inspection. Our team of experts will conduct a thorough inspection of your facility, review your documentation, and provide you with valuable feedback on areas that need improvement to ensure compliance with FDA regulations.
Our Mock & Pre-Approval FDA Inspection Services include:
Facility Inspections
We will conduct a comprehensive facility inspection to assess current Good Manufacturing Practices (cGMP) compliance, including hygiene, equipment maintenance, documentation, and quality control systems. Our experienced inspectors will identify potential deficiencies and provide guidance on corrective actions to ensure successful FDA inspections.
Documentation Reviews
Our team will review your documentation, including labeling, batch records, procedures, and verification and validation activities. We will ensure that your documentation meets FDA guidelines and will provide recommendations for any deficiencies.
Team Training
We offer customized training programs to help educate your employees on the latest FDA regulations to help ensure compliance. Our training programs are designed to make sure that your staff has a comprehensive understanding of the regulations and how they apply to your business.
Report Generation
Upon completion of the comprehensive inspection, our team will provide a detailed report (similar to an FDA 483) that includes observations, findings, and recommendations for improving compliance with FDA regulations. Our report will help you identify areas for improvement and develop action plans to address noted deficiencies before a real FDA inspection.
5 Reasons Why You Should Perform a Mock Inspection:
1. Prepare for the real audit:
Conducting a mock FDA inspection can help a pharmaceutical manufacturer identify areas of inefficiencies, flaws, and non-compliance. The manufacturer can then take corrective action ahead of the actual FDA inspection, ensuring they pass the official audit with flying colors.
2. Ensure continuous compliance:
A mock FDA inspection helps pharmaceutical manufacturers maintain their compliance with FDA regulations. It helps to identify any potential gaps in the manufacturing, documentation, or quality management systems, providing an opportunity to rectify it before the real audit.
3. Boost quality:
A mock FDA inspection can improve the quality of pharmaceutical products. It enhances the company’s understanding of FDA regulations and requirements, promoting a proactive approach to quality management that ensures the products meet the highest quality standards.
4. Enhance reputation:
A successful mock FDA inspection can boost the reputation of a pharmaceutical manufacturer, demonstrating their commitment to quality and compliance with regulatory standards.
5. Save money:
Conducting a mock FDA inspection can save pharmaceutical manufacturers significant costs associated with reworks, recalls, or penalties that may result from failed FDA audits. It is a proactive approach that guarantees compliance and avoids serious implications for the company.
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ADVANCE. CONFIDENTLY.
As long-standing leaders in technical and regulatory consulting services, APAC FDA Consulting provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.
