Warning and Untitled Letters / Critical EU Agency Findings

  • Overview
  • Why Work With NSF?

Warning letters and untitled letters are issued by the FDA for significant regulatory violations that may lead to enforcement actions if not promptly and adequately corrected. They are the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act. Companies must respond to a warning letter within 15 working days of receipt and specify the actions they’ve taken to correct the noted violations.

European regulatory authorities issue a critical inspection finding when a GMP deficiency has produced, or could lead to a significant risk of producing, either a product that is harmful to a human or veterinary patient or a product that could result in a harmful residue in a food-producing animal.

Warning letters, untitled letters and critical findings represent serious issues that may require extensive remediation of quality systems. NSF Pharma Biotech experts have assisted numerous companies with responses to warning letters, untitled letters and critical findings and with developing corrective action plans to ensure that the violations are corrected. We help the company interface with the FDA or EU authority during the initial response and in subsequent follow-up communication to update the remediation efforts. Our team can help develop and implement corrective action plans to ensure remediation efforts are done in a timely, compliant and sustainable manner.

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 and UK MHRA inspectors and experts with decades of experience helping companies develop strategic plans to address warning letters, untitled letters and critical EU agency findings.  Our experts have a proven track record for addressing the most complex regulatory problems and compliance issues.

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