Form 483 Compliance

Medical Device Manufacturers receive observations, warnings &/or Form 483s that require substantial number of unplanned resources, budgets & at the worst are declined an opportunity to sell, shutting down facilities and even prosecution of responsible individuals until the observations are cleared.

Form 483 observation is issued by USFDA following an audit of the company’s manufacturing facility. The document outlines any violations of Good Manufacturing Practices (GMPs) such as the facility, equipment, processes, controls, products, employee practices or records and can be made compliant by IZiel team.

IZiel team provides Form 483 compliance by providing expert remediation services and complete the remediation project effectively and accurately. Form 483 Compliance requires the application of best practices in design and development while ensuring compliance with regulation to ensure a speedy and compliant design and development process.

 Form 483 Compliance – IZiel Approach

IZiel team in collaboration with the customer utilize an extensive & comprehensive methodology to complete the remediation project as depicted below –

Why IZiel Healthcare –

IZiel collaborates with your team to comply with Form 483 observations using process driven & outcome-based delivery approach with quick scalability of resources, sound project management and flexible onshore-offshore model throughout all phases of the remediation are the key enablers of success.

  • Conduct Comprehensive & Methodical Gap Assessment
  • Outcome Based Delivery Approach
  • Quick Scalability of Skilled Resources in –
    • Design
    • Process Engineering & Validation
    • Systems Engineering
    • Software Validation & Testing
    • QMS and CAPA
    • Regulatory
  • Strong Project Management
  • Assist in complete implementation partnering with Remediation/MDR Experts
  • Flexible Onshore/Offshore Model
  • Significant Time and Cost Advantages

Our founding principles to make products Form 483 Compliant –