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Volume 2019 eBook, Issue 5
Warning letters tell the tale of missteps by drug companies and offer a path to compliance for quality teams that monitor these enforcement actions.
While the number of warning letters issued by FDA has declined slightly, recurrent violations include poorly maintained equipment and facilities, insufficient cleaning validation, inadequate written procedures for quality testing, and inadequate controls over data and computer systems. Effective, ongoing monitoring programs-for regulatory agency enforcement actions and pharmacopoeia updates-are essential for bio/pharma compliance.
eBook: Regulatory Sourcebook, December 2019
When referring to this article, please cite it as R. Peters, “Warning Letters Signal Steps to Compliance," BioPharm International Regulatory Sourcebook eBook (December 2019).