Mumbai-based pharmaceutical company Aarti Drugs’ Tarapur facility received an updated warning letter from the US Food and Drug Administration saying that the corrective actions taken by the company to rectify FDA-related violations seen in its manufacturing practices were not sufficient.
The regulator said it may withhold approval of new drug applications which list Aarti Drugs as the active pharmaceutical ingredient (API) manufacturer if the violations are not corrected.
The company, which posted net sales of R218.59 crore in the first quarter, received a warning letter in late 2012 which identified deviations from current good manufacturing practices (CGMP) as defined by the USFDA - to which it responded in Nov-Dec 2012.
The new letter questions the corrective actions employed by Aarti Drugs and asks for further information.
“We have already submitted an initial response to USFDA. In addition to that, we have already hired a USA based FDA consultant to further review our responses and send another detailed response by 15th October. We are putting efforts to further enhance the quality systems to avoid such things in future. Aarti Drugs continues to cooperate with FDA to resolve the issues at the earliest,” the company, which has one more USFDA certified plant in Sarigam, Gujarat, said in a statement submitted to the BSE.
The USFDA listed four points in the latest letter, where it found the corrective actions taken by the company inadequate. Recording manufacturing steps in the log before they occurred, failure to review impact of power outage on quality of products, failure to maintain laboratory records and failure to maintain audit trail for laboratory computer systems were the deviations listed in the updated warning letter.