FDA Enforcement Response & Remediation
- FDA deficiency and Additional Information (AI) response strategy
- Warning Letter response: root cause analysis, CAPA, and response drafting
- FDA Form 483 response: observation-by-observation strategy
- Recall strategy, classification planning, and FDA coordination
- Field Safety Corrective Action (FSCA) planning and documentation
- Consent Decree advisory and Import Alert response strategy
- Lifecycle management: modifications, line extensions, and new indications