IPCA Labs receives USFDA's import alert for MP plant
The company had voluntarily suspended API shipments from its Ratlam (MP) facility for the US market, after it received Form FDA 483 from USFDA in July 2014
BS B2B Bureau B2B Connect | Mumbai
US FDA had inspected IPCA Labs’ active pharmaceutical ingredients (APls) manufacturing facility at Ratlam in July last year, after which the drug regulator had issued certain inspection observations in Form FDA 483 – notifying the company’s management of objectionable conditions. Consequent to this, IPCA Labs voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed.
“We now wish to inform you that US FDA has issued an import alert to the said manufacturing facility on January 22, 2015,” said IPCA Labs in BSE filing.
Also Read
“The company is fully committed in resolving this issue at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture,” added IPCA Labs.
More From This Section
Don't miss the most important news and views of the day. Get them on our Telegram channel
First Published: Jan 23 2015 | 6:00 PM IST