DETROIT, Nov. 3 /PRNewswire-FirstCall/ -- On October 31, 2008, Caraco Pharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) received a warning letter from the FDA. The 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. As previously disclosed, a Form 483 notice was issued in June 2008 following this inspection. The Company had responded to all the observations made in the Form 483 within thirty days thereof, and corrective actions were taken and substantially completed. Subsequent letters noting additional improvements were also provided to the FDA similar to what the Company has done in previous correspondence with the FDA. The observations set forth in the warning letter include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the Company's standard operating procedures. The FDA considered some of its observations to be repeat observations. The Company believes that the full warning letter, listing all of the observations, will be posted by the FDA shortly on its website at http://www.fda.gov .
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.
Caraco intends to respond promptly and timely to the FDA within fifteen business days. The Company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter. Caraco is confident that any remaining concerns will be addressed and resolved.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
manufactures, markets and distributes generic and private-label
pharmaceuticals to the nation's larges
|SOURCE Caraco Pharmaceutical Laboratories, Ltd.|
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