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FDA Warning Letter calls explicitly for CAPA - 10 May 2016

The U.S. Food and Drug Administration FDA has recently issued a Warning Letter showing the Agency’s focus on Data Integrity.

This warning letter to an India based pharmaceutical company contains GMP observations in four areas:

In the description of the observations data integrity deficiencies are repeatedly highlighted and the conclusions states that the quality systems do not adequately ensure the accuracy and integrity of the data generated at by the company to support the safety, effectiveness, and quality of the drug products manufactured.

It is also noted that the FDA clearly proposes some necessary actions and asks for appropriate corrective and preventive actions (CAPA) which although is unusual suggests a trend in the Agency’s warning letters:

The reasons for this might be connected with the Agency’s concern with the company's first response. The proposed actions of the company were "insufficient to correct the broad data manipulation and deletion problems observed at your facility and to prevent their recurrence." FDA further requests that the response should clearly demonstrate "an assessment of the effectiveness of these newly implemented system controls" should be provided.

Source: GMP Compliance news

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