Sun Pharma has not revealed the reason why FDA sent the observation.
Sun Pharmaceutical Industries, the Indian pharma giant that has been on the watch list of the US Food and Drug Administration (FDA), has received yet another observation from the health regulator after it conducted an inspection at the Halol facility.
Sun pharma has acknowledged that the FDA had conducted an inspection at its Halol Facility that was earlier banned from manufacturing any new medicine. The company said that the inspection was completed on December 1 and last week it received a form 483 observation letter from USDA asking it to reply within 15 days.
Form 483 is issued by FDA only when it finds the company failed to follow the guidelines set by Food Drug and Cosmetic act and its related acts.
In the usual scenario, Form 482 is sent after FDA agents find conditions or practices adopted by any food, drug, device or cosmetic manufacture adulterated or when they find the items being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
Sun Pharmaceutical Industries said in a BSE filing that their “Halol facility has undergone an inspection by the US Food and Drug Administration (USFDA) recently. The inspection was completed on December 1, 2016. A Form 483 observation letter was issued by the USFDA post the inspection.”
As of now, the company has not revealed the reason why FDA sent the observation.
“We are currently in the process of responding to the said letter to the USFDA within the stipulated timeline of 15 days,” it added.
This is the second time in two years that FDA is issuing a warning to the Indian pharma company specifically with regard to the functioning of its Halol facility. An earlier inspection conducted in September 2014 by FDA had found irregularities, following which it served a notice in December 2015.
The company was banned from manufacturing new products in the Halol facility and the USFDA had withheld future product approvals. Since then the company has been implementing efforts to make the Halol plant CGMP-compliant again.
Shares of Sun Pharmaceutical Industries were trading 5.15 per cent down at Rs 669.65 on BSE.