Special Services

We are available to assist clients with special projects that require
expert experience in areas as follows:

  1. FDA Compliance Follow-up for FDA inspections, FDA-483s, and Warning Letters
  1. FDA Inspection Readiness Training
  1. Mock FDA Inspections
  1. Auditing Certification and services
  1. CAPA and nonconformance material handling
  • Investigation
  • Root Cause Analysis
  • Consulting
  1. Communications/Representations to FDA
  • Denver District Office
  • Cincinnati District Office
  • FDA Headquarters (Office of Compliance and Office of Device Evaluation)
  1. 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
  1. 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

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