May 3, 2021 | Mark Paradies

Florida Contract Manufacturer Warned by FDA to Perform and Improve Root Cause Analysis on Issues

The FDA Wants Good Root Cause Analysis

Once again, the FDA warned a drug manufacturer that, among many findings, they were not conducting adequate root cause analysis and corrective actions of assay failures. For the complete letter, CLICK HERE.

Multiple Findings Indicate Poor Root Cause Analysis and CAPA on Previous Issues

In addition to the FDA’s specific warnings about the root cause analysis of assay failures, the repeat nature of many of the other findings indicates that previous FDA warnings did not receive an adequate root cause analysis and development of effective corrective actions. If adequate corrective actions would have been implemented, there findings would not be recurring.

How Do You Stop Repeat Findings and FDA Warning Letters?

Implementation of good manufacturing practices in the pharmaceutical industry (or other FDA-regulated industries) depends on effective root cause analysis and corrective actions when problems are discovered. Insufficient root cause analysis leads to repeat failures and FDA regulatory attention.

To improve root cause analysis we recommend adopting a proven system with advanced human performance and equipment reliability troubleshooting tool that are built into the system. We recommend a system that has been proven in many industries. We recommend a system that can be used on precursor incidents and major quality issues. We recommend the TapRooT® Root Cause Analysis System.

Learn More About TapRooT® Root Cause Analysis

investigation
Course Participants Working on an Exercise

The best way to learn more about TapRooT® Root Cause Analysis is to attend one of our courses.

The 2-Day TapRooT® Root Cause Analysis Course and the 3-Day Virtual TapRooT® Root Cause Analysis Course teach the essential techniques to find and fix the root causes of precursor incidents.

For dates and locations for our Public 2-Day Courses, CLICK HERE.

Virtual TapRooT®  Root Cause Analysis Training
Behind the Scenes, Virtual TapRooT® Root Cause Analysis Training

For dates and locations for our Public 3-Day Virtual Courses.

For more about our other root cause analysis training, CLICK HERE.

For a quote for on-site training, contact us by CLICKING HERE or calling 865-539-2139.

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Quality
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