6 Tips to avoid 483 letters

 

The U.S. Food and Drug Administration (FDA) is authorized to perform random inspections and audits, and these inspections can lead to FDA warning letters and FDA Form 483 observations. 


Medical device manufacturers receive observations (Form 483) 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.

Some tips to avoid a warning letter and form 483 observation –

  • ·         Be Inspection Ready
  • ·         Clearly Written Standard Operating Procedures
  • ·         Proper Document Control
  • ·         Develop a Compliance Culture
  • ·         Correct Observations Real-time
  • ·         A Hyper-adaptive Quality Management Software

IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy. IZiel team in collaboration with the customer utilize an extensive & comprehensive methodology to complete the remediation project. Our Onshore-Offshore Model with strong project management ensure deliveries with faster timelines, flexible resources and in cost-effective manner.


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