FDA 483 - FDA Warning letter

FDA inspect medical device companies against the GMP (21 CFR 820 ) requirements, if the firm is not complying with GMP at the time of inspection, FDA will issue Form 483 with non-conformities observed during the inspection. Examples of observations in FDA 483 are.

  • Personnel training is not documented
  • Design History File (DHF) not maintained
  • Device History Record (DHR) not maintained
  • Customer complaints not investigated and documented
  • Corrective and Preventive action (CAPA) not documented

After receiving FDA 483, The firm must send a response letter to FDA with an action plan describing how you will correct the deficiencies, the plan must also include specific period for each activity.

If the response to FDA 483 is not adequate FDA will issue a warning letter, FDA issue warning letter only for significant violations. This is also an opportunity for the establishments to comply with Quality system regulations.

LMG provide assistance in

  • FDA 483 Response letter
  • Closing non-conformities
  • GMP Compliance
  • 21 CFR 820 Implementation
  • FDA Pre-inspection support

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