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