Glossary Term
Mock FDA Inspection
Definition
Mock FDA inspections are simulated audits conducted by internal quality teams or third-party consultants to prepare a company for an official inspection by the U.S. Food and Drug Administration (FDA). These inspections follow FDA guidelines and protocols, helping organizations identify and address compliance gaps in their quality management systems, processes, and records.
Relevance to the MedTech Industry
Mock FDA inspections help medical device manufacturers proactively identify and correct deficiencies to ensure compliance with regulatory requirements, such as FDA 21 CFR Part 820 (Quality System Regulation). By simulating real inspection scenarios, companies can reduce the risk of non-compliance findings and establish a culture of audit readiness.
Additional Information & Related Terms
Related Terms
FDA Inspection: An official audit conducted by the FDA to evaluate a company’s compliance with regulations.
21 CFR Part 820: The FDA’s Quality System Regulation for medical device manufacturers.
Corrective and Preventive Actions (CAPA): A systematic approach to identifying and addressing non-conformances in processes or products.
Audit Readiness: The state of being prepared for regulatory inspections or internal audits.
Risk Management File: A record of risk analysis and mitigation activities, often reviewed during inspections.