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483, Warning Letter, and Consent Decree Remediation Services

Is your company expecting an inspection from a regulatory agency?                                                                                                                                                    
Have you received a 483, Warning Letter, or are you under Consent Decree?

Our experienced staff can assist you in all stages i.e. pre-inspection, during regulatory inspection, post regulatory inspection with the following:

  • Resolution of regulatory agency observations such as 483s, Warning Letters, and Consent Decrees
  • Participate in regulatory agency meetings to address and resolve deficiencies
  • Assistance during regulatory agency inspections
  • Training of employees and management to prepare for a successful regulatory agency inspection
  • Internal inspections for:
    • FDA (Food and Drug Administration)
    • MHRA (Medicines and Healthcare products Regulatory Agency)
    • OSHA (Occupational Safety and Health Administration)