Regulatory Focus™ > News Articles > Indian Company's Drugs Relied on Fraudulent Testing Practices, FDA Says

Indian Company's Drugs Relied on Fraudulent Testing Practices, FDA Says

Posted 25 February 2014 | By Alexander Gaffney, RAC

For the eighth time in the last year, an Indian pharmaceutical manufacturer has been accused by US Food and Drug Administration (FDA) inspectors of falsifying data used to support approval and ongoing maintenance of drug products.

Background

As Focus previous reported, Indian companies have been the subject of increasing amounts of FDA scrutiny.

But unlike most Warning Letters, those sent to Indian companies have been among the most serious issued by FDA. At issue in seven previous letters has been allegations of data falsification. Companies were, in effect, either caught tampering with data or lacked sufficient safeguards to prevent the practice from occurring.

Warning Letter Issued To

Date Warning Letter Issued

Wockhardt Limited

11/25/2013 

Agila Specialties Private Limited

09/09/2013 

Posh Chemicals Private Limited

08/02/2013 

Aarti Drugs Limited

07/30/2013 

Wockhardt Limited

07/18/2013 

Fresenius Kabi Oncology Ltd

07/01/2013 

RPG Life Sciences Limited

05/28/2013 

A New Warning Letter to USV

Now yet another Indian manufacturer is in the sights of FDA, once again charged with data falsification.

In a 6 February 2014 Warning Letter to USV Limited, a Mumbai-based control laboratory testing facility, FDA wrote that its inspectors had found troubling practices.

In one noted practice, FDA alleged that the company's analysts didn't document the sample weights at the time they were weighed. Instead, FDA said, the sample weights were recorded after chromatographic runs. Such practices would allow the company to make it look like a sample met standards and lacked impurities, when it might not have.

These data were apparently used to support several drug applications, though FDA omitted the names of those drugs from the Warning Letter. "The lack of reliability and accuracy of data generated by your firm is a serious CGMP deficiency that raises concern for all data generated by your firm," FDA wrote.

Other aspects of the company's operations also supported potential data falsification, FDA said. As with several other Indian companies, USV was alleged to lack adequate control over its computerized systems, allowing its employees to delete data from analyses. The system also did not have a functioning "audit trail" at the time of the inspection, making it impossible to determine what data were changed and when, FDA said. Even if such a system were in place, FDA found that many employees use the same log-in credentials, making accountability impossible.

In still more observations, FDA found that computers lacked regular backups, meaning that quality data might be lost if a computer crashed.

Stern Admonishment

The culmination of the alleged deficiencies resulted in one of the sternest admonishments of any company Focus has come across in any Warning Letters to date:

"The deviations listed above, as well as other deficiencies our investigator found, lead us to question the basic effectiveness of your current quality system to achieve overall compliance with CGMP at your facility. It is apparent that you have not implemented a robust quality system at your firm."

The company had already been subject to a FDA Form 483 for the same inspection, and was also subject to an import refusal around the same time when it tried to export a new drug without an approved new drug application, according to FDA records.

The company was also ordered to provide FDA with a list of "all the batches of drug products shipped to the US market that relied upon missing, inaccurate or unreliable test data."

In addition to USV's Mumbai facility, it also owns and operates eight others, including:

Facility Owner

Location

Facility Description

USV Limited

Maharashtra, India

API Manufacture

USV Limited

Maharashtra, India

API/FDF Analytical Testing

USV Limited

Maharashtra, India

Pack

USV Limited

Maharashtra, India

API/FDF Analytical Testing

USV Limited

Union Territory, India

API Manufacture

USV Limited

Union Territory, India

API/FDF Analytical Testing

USV Limited

Union Territory, India

FDF Manufacture

USV Limited

Union Territory, India

PACK

 

FDA Letter to USV Limited

Do Indian Companies Have a Chronic Data Falsification Problem?


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