Consent Decrees

  • Overview
  • Why Work With NSF?

Companies entering into a consent decree with the FDA have safety and significant current Good Manufacturing Practice (cGMP) deficiencies that require extensive remediation. In many cases, production and distribution activities are halted until companies can demonstrate that the products they manufacture are safe and comply with the Federal Food, Drug, and Cosmetic Act. Companies are generally required to retain a third-party expert to help them develop and submit plans to the FDA to correct the violations found by the agency.

NSF Pharma Biotech has helped many companies throughout the consent decree process. Our experts have helped interface with the FDA and establish corrective action plans (work plans) to guide the required remediation efforts. We have managed project teams to implement the remediation efforts and have served as independent third-party verifiers to ensure the adequacy and compliance of remediation efforts. Our professionals can guide the development of compliant, practical and sustainable solutions.

For more information about NSF Pharma Biotech regulatory enforcement action support in the U.S., email uspharma@nsf.org or call +1 202.822.1850.

For more information about NSF Pharma Biotech regulatory enforcement action support in Europe, email pharmamail@nsf.org or call +44 1751 432 999.

Why Work With NSF?

Our team includes former U.S. FDA inspectors and experts with decades of experience helping companies develop strategic plans to navigate their way through and out of consent decrees.  Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues.

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