Caraco Pharmaceutical Laboratories, Ltd. (CPD) announced that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008.
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's sales of current products continue in the normal course of business.
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