A negative report on a compliance audit can be devastating, but it doesn’t have to be a crippling setback. ECI-Rx can get you back on track with our non-compliance remediation services.
Companies often choose to delay large-scale compliance efforts due to many extraneous factors.
- Mergers and acquisitions
- Organizational deficiencies
- Out of sight, out of mind attitude
Whatever the reason, ECI-Rx can help companies recover from non-compliant status. If you’ve received an FDA warning letter, consent decree or Form 483, contact ECI-Rx immediately.
- 483s/Warning Letter/Consent Decree
- Quality Audits
- Audit Responses
- Corrective Action and Preventive Action (CAPA) / Root Cause Analysis
- Post-Market Surveillance
- Product Recalls / Field Action
- Technical Documentation / DHF Remediation
- Risk Management