USFDA issues import alert to IPCA labs’ two manufacturing sites
IPCA Labs has received US Food and Drug Administration (FDA) import alert for two of its Active Pharmaceutical Ingredient (API) manufacturing units in Pithampur & Silvassa in March, 2015. Their Ratlam facility which was their biggest USFDA approved facility too was given an import alert in January, 2015. IPCA has received Form 483 due to Data integrity issues. Tests for checking the quality of the products have been repeated and original data have been deleted. So the quality of the products cannot be specified because the original test data were deleted.
Ipca Laboratories is engaged in manufacturing of active pharmaceutical ingredients and formulations. Worldwide the company is one of the largest suppliers of APIs and intermediates.