Compliance Audits

Our compliance audit services provide comprehensive evaluations of your fertility clinic's operations to ensure compliance with FDA regulations and industry best practices. At The FDA Consultants, we understand the critical importance of maintaining high standards of patient safety, documentation accuracy, and adherence to FDA requirements. With our expertise, we offer both Onsite and Offsite audits to assess various aspects of your clinic's compliance, including patient records, QA/QC/QI records, FDA compliance, and mock inspections.

Patient Records Audit:

  • Evaluation of accuracy, completeness, and compliance of patient records

  • Review of donor eligibility, screening procedures, and documentation

  • Verification of informed consent, medical histories, test results, and tracking of tissue products

  • Enhancing patient safety and facilitating efficient record-keeping processes

QA/QC/QI Records Audit:

  • Assessment of quality assurance, quality control, and quality improvement practices

  • Review of documented procedures, protocols, and monitoring systems

  • Identification of gaps and areas of improvement in quality management practices

  • Establishing robust systems for maintaining quality standards and improving patient care

FDA Compliance Audit:

  • A comprehensive evaluation of compliance with FDA regulations

  • Examination of labeling, record-keeping, tissue handling protocols, and reporting requirements

  • Identification of areas requiring attention or improvement

  • Mitigation of risks, ensuring regulatory compliance, and maintaining high patient care standards

Mock Inspections:

  • Simulation of onsite and offsite FDA inspections

  • Evaluation of clinic's readiness and identification of areas of concern

  • Comprehensive assessments of operations, facility layout, documentation, and compliance practices

  • Identifying weaknesses, implementing necessary improvements, and enhancing preparedness for actual FDA inspections

By choosing The FDA Consultants for your compliance audits, you gain access to our expertise and extensive knowledge of FDA regulations in the context of fertility clinics. We provide detailed reports, actionable recommendations, and ongoing support to help you address any identified compliance gaps. Our goal is to assist your clinic in achieving and maintaining the highest level of compliance, patient safety, and regulatory excellence.