FDA Inspection Remediation


Has your organization received a FDA Warning Letter, or threatening to place your organization under a Consent Decree? If you are in a challenging position with the FDA, we are here to help. Effectively responding to these regulatory deficiencies requires cohesive planning and thorough documentation. Synergy Bioscience can help you assemble a complete FDA response package. Out auditors and consultants have comprehensive experience with the processes and procedures related to compliance with the US FDA regulations, as well as Canadian, European, British, Australian, Japanese, and ISO requirements. Experienced professionals at Synergy Bioscience will partner with you to help revamp and resolve deficiencies in your Quality System. These experts are capable of providing pre‐inspection audits for all functional areas and can assist with the remediation of formal inspection findings such as FDA 483, warning letter, consent decree, application integrity policy (AIP), and notified body review report.

Synergy Bioscience has tremendous experience with developing and updating quality systems to ensure compliance will the regulatory requirements, and have managed and executed all levels of remediation activities (Consent Decrees/Warning Letters/Form 483).


  • Analyzing the findings of the warning letter or the Consent Decree.
  • Gathering supporting documentation to file with the response
  • Creating a timeline that meets agency expectations
  • Answering any of your questions or questions from the FDA
  • Developing the compliant course of action that will ensure putting your business back to compliance and sustainable growth.

Unlike cookie cutter solutions that other consulting companies usually offer, Synergy Bioscience will help you develop and implement the sustainable compliant approach that will fit your business needs.

All Synergy Bioscience training courses are modules that can either be taught at your location, or remotely by Webinar. Due to our extensive list of courses, contact us about a specific course and we will send out all the details. Additionally, as part of our training service, we will work with your staff to match your organization with the proper trainer, and devise a training schedule that fits around your employee’s primary tasks

To discuss how Synergy Bioscience can help you, please contact us