Bhavesh Patel, managing director of Marck Biosciences (which has re-branded itself as Amanta Healthcare) said that "The FDA has suggested that we appoint an external consultant to help us address the issues raised by the US drug regulator, and we plan to do that." Meanwhile, he also mentioned that while the USFDA letter is dated July 8, the company received it only a few days back, and hence, would seek some more time from the FDA to prepare its answers.
Patel also noted that while the FDA officials had visited the plant in November last year, this warning letter came in so late. "We are also quite puzzled as to why the US FDA has issued this letter nine months after there was filing of our response and completion of compliance which was subsequently validated by inspections undertaken by the health authorities of other countries." He also claimed that as Marck Biosciences is currently not exporting to the US, the import alert issued by the FDA will not have any practical impact.