Sun Pharma's US arm, Caraco Pharmaceutical, will file a response to the US Food and Drug Administration's (USFDA) warning on its quality standards tomorrow.
Two weeks ago, USFDA had issued a warning to the company that its quality and processes were not up to specifications. The warning came after the company's Detroit facility was inspected in May.
However, the company maintained that the warning was not with regard to product quality, but on the systems and processes in the facility.
"The USFDA letter to Caraco was referring to some quality concerns on the systems and processes of the company and not about product quality," a Sun spokesperson said here.
USFDA had asked Caraco to reply back in 15 days.
"The company is committed to working cooperatively and expeditiously with the FDA to resolve matters indicated in its letter," Caraco said in a statement.
USFDA, which had carried out the inspection in May, had found certain incidents contrary to the company's standard operating procedures.
