Sun’s troubled Halol plant earns another FDA 483

By Dan Stanton

- Last updated on GMT


Related tags Food and drug administration

The latest US FDA inspection at Sun pharma’s facility in Halol, India has ended with a Form 483 with three observations.

According to a filing with the Bombay Stock Exchange made by Sun Pharmaceutical Industries last week, the US Food and Drug Administration (FDA) inspected the Halol facility in the Gujarat state between February 12 and 23.

“At the conclusion of the inspection, the agency issued a Form 483, with three observations,”​ the firm stated.

“The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. The company is committed to addressing these observations promptly. The company remains committed to working closely with the US FDA and continues to enhance its GMP compliance on an ongoing basis.”

Nine to three

While the 483 is not good news for the site, the three observations is at least an improvement on the facility’s last FDA inspection in December 2016​ which ended with a 483 and nine observations.

It is, however, the latest in the ongoing saga between the FDA and the finished pharmaceutical production plant.

As a result of shortages​​ in 2012 – caused by problems at J&J's supplier Ben Venue – the FDA temporarily allowed Sun to produce a generic version of the cancer drug Doxil (doxorubicin hydrochloride) at the site for the US market.

And in 2015 the firm won approval for its drug epilepsy drug Elepsia (levetiracetam) made at the plant.

However, the regulatory Agency reversed its decision​ due to cGMP issues at the plant that resulted in a warning letter​ issued to the firm.

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