ROLE OF FDA 483 OBSERVATIONS IN QUALITY MANAGEMENT SYSTEMS: ENHANCING COMPLIANCE AND RISK MANAGEMENT

Abstract

Regulation of the life sciences arena by the U.S. Food and Drug Administration (FDA) through inspection and issuance of Form 483 observations is vitally importance to patient safety and the public’s overall confidence in life science products. This review highlights the purpose of FDA 483s as a source of information to advance Quality Management Systems (QMS) and risk management in regulated work, such as pharmaceuticals, medical devices and biotechnology. It also serves as an overview to show how these FDA 483 observations assist companies to identify regulatory non-compliance, direct corrective action and stimulate ongoing improvements in the organizational quality framework. The authors also discuss how organizations can employee 483 observations as input to a risk assessment and to address trends in FDA enforcement actions and corrective actions to minimize compliance risk. Moreover, the examination of trending data helps to illustrate how effective use of FDA 483 observations influence organizational culture that enhances a proactive culture, as well as improved regulatory compliance and risk assessment frameworks Organizations determined to stay ahead in regulated environments, informed and utilized 483 observations foster continuous regulatory alignment in their organizational framework. Finally, to ensure ongoing and enhanced credibility in regulated environments, the evidence from 483 observations highlighted in this review demonstrates the increasing importance of their use in the circumstance of overall global regulatory harmonization, current and future technology, and advancing themes of compliance management.