Caraco Pharmaceutical Laboratories, Ltd. (CPD) announced Monday that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008. In the warning letter, the FDA requested a response from Caraco within 15 business days, ending November 24, 2008.
As disclosed earlier, the warning letter was issued as a follow up to the last FDA inspection of the company's manufacturing facility in Detroit, Michigan, which was initiated in May 2008.
Until the company's responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the FDA may in the near term withhold approval of pending new drug applications listing the facility as the manufacturer.
The company noted that its sales of current products continue in the normal course of business.
Further, the company has requested a meeting with the FDA as a follow up to its response.
For comments and feedback: editorial@rttnews.com