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Lab Data Integrity at Issue in FDA Warning Letters Sent to China and India

Jun 13th, 2011

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Evidence of unreliable laboratory data has prompted the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER) to issue warning letters over the past few months to drug manufacturers in China and India.

In late March, the compliance office sent a warning letter to API producer Ningbo Smart Pharmaceuticals, located in Ningbo, China, citing the firm for releasing batches based on fictitious results from lab tests that were not performed. The letter reflected investigator findings from an inspection conducted last October.

Aurobindo Pharma received a warning letter in late May in which the integrity of the data collected from the firm’s environmental monitoring program for sterile API and injectable cephalosporin production at its Unit VI plant in Hyderabad, India was brought into question.

The December 2010 inspection referenced in the Aurobindo letter resulted in an FDA import alert being placed on cephalosporin products from Unit VI in late February.  The products named in the alert included four injectable cephalosporins that were being contract manufactured for Pfizer – cefazolin, cefotaxime, ceftazidime and ceftriaxone.  The four were part of a larger contract arrangement reached in 2009 for Aurobindo to manufacture over 50 Pfizer products.

The two warning letters underscore FDA’s concern with the integrity of lab data as the foundation for the credibility of  a company’s quality organization – a concern that has not been subsiding in the wake of the agency’s findings at various types of facilities abroad, particularly in India and China.  The letters also speak to FDA’s increasing emphasis on contractor and supplier oversight.

The highest profile of the recent cases where integrity was at issue was that of the large Indian-based generic drug manufacturer Ranbaxy. FDA’s findings included falsified data and test results in approved and pending drug applications, and resulted in an import alert being placed on over 30 of Ranbaxy’s drug products in 2009 (IPQ May/June 2009 Report).

[More analysis of the Ningbo and Aurobindo warning letters is provided for subscribers beginning on page 2.  Nonsubscribers may purchase the full story for $95 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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