 "US FDA issues warning letter for Ipca Labs' 3 plants")
The Mumbai-based pharma company Ipca Laboratories has received a warning letter from US Food & Drug Administration (FDA) for its three manufacturing units located at Ratlam (Madhya Pradesh), SEZ Indore (Pithampur) and Piparia (Silvassa).
The US FDA officials inspected these three manufacturing units between July 2014 and March 2015. After inspection, these units received certain observations in Form 483 and which subsequently resulted in issuance of import alert on these manufacturing units. Yesterday, Ipca informed that US FDA has issued a warning letter to these manufacturing units.
The company had voluntarily suspended shipments of its active pharmaceutical ingredients (APls) and formulations for the US market till US FDA inspection observations are resolved. Therefore, since July 2014 Ipca has not shipped any APls or formulations to US market except the products which are exempted from import alert.
“The company has responded to the US FDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner. Since the inspection, Ipca has regularly communicated with US FDA with periodic updates on remedial measures undertaken. The company is fully committed in resolving this issue at the earliest,” said Ipca Laboratories in a BSE filing.
The US FDA officials inspected these three manufacturing units between July 2014 and March 2015. After inspection, these units received certain observations in Form 483 and which subsequently resulted in issuance of import alert on these manufacturing units. Yesterday, Ipca informed that US FDA has issued a warning letter to these manufacturing units.
The company had voluntarily suspended shipments of its active pharmaceutical ingredients (APls) and formulations for the US market till US FDA inspection observations are resolved. Therefore, since July 2014 Ipca has not shipped any APls or formulations to US market except the products which are exempted from import alert.
“The company has responded to the US FDA inspection observations with its remediation measures and has been since working also with external consultants to ensure that its remedial activities are undertaken in a proper and timely manner. Since the inspection, Ipca has regularly communicated with US FDA with periodic updates on remedial measures undertaken. The company is fully committed in resolving this issue at the earliest,” said Ipca Laboratories in a BSE filing.