FDA Inspection Preparation and Remediation

FDA Inspection Preparation

BE COMPLIANT STAY COMPLIANT

Is your organization part of continuous inspections? Are you ready for your next inspection? Do you know what the compliance status is of your organization or department Wouldn’t it be a great peace of mind to know that your departments are ready for inspection, at any time?

With our broad experience and know how Rescop can help you to reach this goal.

    • Our software Solutions make Documentation Validation Qualification and CAPA & Deviation Management a smooth journey.
    • Our Team of highly experienced and specialized Consultants can assist you in becoming compliant and staying compliant and prepare you and your organization for inspection by your regional Authority, the FDA or other Government Organizations.

FDA Inspections

One of our core specialties is to guide GxP regulated companies successfully through FDA inspections with FDA Inspection Preparation and Remediation. Our team of experienced compliance consultants can offer the following support:

      • Mock audit / assessment, to determine inspection readiness
      • Training, to ensure that personnel will be prepared for the FDA inspection, covering all aspects that matter for successful audit execution
      • Support in writing the response to an FDA inspection, in case observations were made
      • Support in any remediation activities related to inspection observations
      • Set up a permanent inspection readiness program

We have a long track record of successful FDA inspections, and we are more than happy to provide references.FDA Inspection Preparation