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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