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We are available to assist clients with special projects that require
expert experience in areas as follows:
- FDA Compliance Follow-up for FDA inspections, FDA-483s, and Warning Letters
- FDA Inspection Readiness Training
- Auditing Certification and services
- CAPA and nonconformance material handling
- Investigation
- Root Cause Analysis
- Consulting
- Communications/Representations to FDA
- Denver District Office
- Cincinnati District Office
- FDA Headquarters (Office of Compliance and Office of Device Evaluation)
- Develop/Improve/Implement/Assist with procedures, forms, staff training, etc.
- Quality Manuals, Quality Objectives, and Quality Policies
- Design Controls
- Medical Device Reporting (MDR)
- Complaint Handling
- Failure Investigations
- Production and Process Controls
- Process Validation
- Nonconformities and rework
- Management Reviews
- Internal Audits
- Management Representatives
- Automatic Detention and Import Alerts
- Problem Evaluation and Resolution Strategy
- FDA-483, Inspectional Finding, response to inspections
- Warning Letter responses (including Untitled Letters)
- Quality Management System (QMS) improvement plans
- Corrections and Removals (Recalls)
- Injunctions
- Product Seizures
- Consent Decrees
