The RAPS website recently experienced issues that we continue to monitor.  Certain areas of the site including news may be limited.  We apologize for any inconvenience.

Regulatory Focus™ > News Articles > New FDA Warning Letter, Form 483 for Two Indian Companies

New FDA Warning Letter, Form 483 for Two Indian Companies

Posted 02 May 2017 | By Michael Mezher 

New FDA Warning Letter, Form 483 for Two Indian Companies

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma.

Warning Letter: Sal Pharma

FDA's warning to Sal Pharma comes roughly 10 months after the agency inspected the company's Hyderabad, India facility in June and July 2016. Last February, the agency placed the firm on import alert.

According to the warning letter, Sal Pharma falsified certificates of analysis for its products by replacing the information of the original API manufacturer with its own information.

As a result, FDA says the company's itraconazole and lansoprazole APIs are misbranded, as their labels "falsely represent that Sal Pharma is the sole drug manufacturer."

FDA also says that two of the company's API suppliers were not registered as manufacturers with the agency. Despite this, FDA says Sal shipped API from these companies to the US, claiming itself as the original manufacturer.

Furthermore, FDA says that Sal Pharma was unsure whether or not the clearing agent it used when exporting products was storing API in a temperature controlled environment.

FDA also warned Sal Pharma in 2012 for failing to register as a manufacturing facility with the agency in 2011 and 2012, despite importing or offering to import drugs into the US during that time.

Form 483: Aurobindo Pharma

The Form 483 issued to Aurobindo Pharma follows an inspection of the company's Hyderabad, India facility that ran from 10-18 April.

The inspection report details six observations related to the company's laboratory system, including a repeat observation from an inspection the year before.

While much of the repeat observation is redacted, FDA writes that the company's "laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures."

The agency also says the company's quality control unit did not adequately investigate out-of-specification test results and that the unit's responsibilities and procedures "are not in writing and fully followed."

In a Bombay Stock Exchange filing, Aurobindo said the observations "are all on procedural improvements," and emphasized that none of the observations were related to data integrity and that it would be responding to FDA within the allotted timeframe.

Warning Letter

Form 483

Regulatory Focus newsletters

All the biggest regulatory news and happenings.