Warning Letter – OTC Drug manufacturer data integrity issues

The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered.

One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the past two decades, the FDA has publicly outlined its expectations for the accuracy, reliability and truthfulness of all data and information collected by drug manufacturers. In 2018, the agency updated guidance for industry on ensuring data integrity and compliance with CGMP. The FDA’s data integrity guidance aims to help manufacturers have the tools and systems in place to prevent adulterated products from entering the U.S. marketplace. Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity. This helps ensure the safety, effectiveness and quality of the drug products produced for the American public. When the agency finds manufacturers who are not complying with data integrity requirements, the FDA takes action against those manufacturers’ practices and works to bring them into compliance.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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