"As of January 31, 2016 all the CAPA which were due for completion have been completed," DRL's COO Abhijit Mukherjee told analysts.
He, however, did not share by when issues related to the three plants could be resolved saying, "on the remediation, we certainly cannot provide you any explanatory guidance on the timelines because on our side we are doing whatever we can to mitigate, workout on the CAPAs, update FDA and the overall journey, we think, is progressing satisfactorily. Beyond this (it) is completely the agency's prerogative."
The USFDA in the warning letter issued to the company on November 5 last year had said it found several violations with regard to current good manufacturing practices (CGMP) in API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as in oncology formulation manufacturing facility at Duvvada, Visakhapatnam in AP.
In the warning letter the USFDA has said that DRL did not implement a robust quality system at its sites.
Also Read
The company has also engaged third-party consultants, US-based Lachman consultants to provide necessary compliance and remediation support for assuring robust implementation and verification of the CAPA plan, he added.