FDA Inspection Readiness
Mock FDA Inspections & Audits
We at Lachman Consultants 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:
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.
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.
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.
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.