6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483

 

Medical device manufacturers receive observations (Form 483Compliance) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.

Companies 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. Companies may also undertake product remediation to resolve issues that they are aware of in their product design and development process.


The 6 biggest ways an experienced compliance and remediation consulting firm can help those recovering from a Warning Letter (Form483 Compliance) or FDA Warning Letter

  • ·         Objective, un-biased perspectives 
  • ·         A comprehensive understanding of CAPA
  • ·         An eye for spotting compliance gaps you may otherwise miss
  • ·         Knowledge of an ever-changing regulatory environment 
  • ·         Strong relationships with FDA
  • ·         Access to former FDA staff

 

IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.


IZiel team follows a detail-oriented approach and works with the engineering and quality teams to ensure that all the necessary documentation for design, process validations, software validations, risk management along with compliant quality system procedures are created. We adopt the V-Model methodology along with a Design for Six Sigma approach to document and validate the product. In the process, we also train the engineering and the quality teams at the client’s location and ensure a lasting change is made in the organization to continue producing quality products consistently.

 



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