In a move that could impact future approvals of some of its new drug applications in the US, Sun Pharmaceutical Industries (SPI Inc), a wholly-owned subsidiary of Sun Pharma, said it received a warning letter from the US Food and Drug Administration (USFDA).
?This letter was issued by the USFDA as a follow up to the last inspection of the SPI Inc manufacturing facility in Cranbury, New Jersey, US, initiated in February 2010 during which the USFDA had identified violations of current good manufacturing practice (cGMP) regulations. SPI Inc has undertaken immediate corrective actions,? a media release from Sun stated on Tuesday.
?SPI Inc intends to respond promptly to the USFDA within 15 working days. SPI Inc is committed to working cooperatively and expeditiously with the USFDA to resolve the matters indicated in its letter,? the release added.
This is the second such incident involving a Sun Pharma subsidiary and the USFDA. In November 2008, Caraco Pharmaceuticals, another subsidiary of Sun Pharma, received a warning letter from the USFDA over the company?s manufacturing facility in Detroit. This was on the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company?s standard operating procedures.