FDA 483 - FDA Warning letter

FDA inspects 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 it will correct the deficiencies; the plan must also include a specific period for each activity.

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

LMG assists in

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

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