DETROIT, Nov. 3 On October 31, 2008, CaracoPharmaceutical Laboratories, Ltd. (NYSE Alternext US: CPD) received a warningletter from the FDA. The letter was issued as a follow up to the last FDAinspection of the Company's manufacturing facility in Detroit, Michigan whichwas initiated in May 2008. As previously disclosed, a Form 483 notice wasissued in June 2008 following this inspection. The Company had responded toall the observations made in the Form 483 within thirty days thereof, andcorrective actions were taken and substantially completed. Subsequent lettersnoting additional improvements were also provided to the FDA similar to whatthe Company has done in previous correspondence with the FDA. Theobservations set forth in the warning letter include, among other things, theinadequate and untimely investigation by the quality control unit of certainincidents at the facility contrary to the Company's standard operatingprocedures. The FDA considered some of its observations to be repeatobservations. The Company believes that the full warning letter, listing allof the observations, will be posted by the FDA shortly on its website atwww.fda.gov .
Until the Company's responses to the observations have been clarified andexplanations provided to the satisfaction of the FDA, the FDA may in the nearterm withhold approval of pending new drug applications listing the facilityas the manufacturer.
Caraco intends to respond promptly and timely to the FDA within fifteenbusiness days. The Company is committed to working cooperatively andexpeditiously with the FDA to resolve the matters indicated in its letter.Caraco is confident that any remaining concerns will be addressed andresolved.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,manufactures, markets and distributes generic and private-labelpharmaceuticals to the nation's largest wholesalers, distributors, drugstorechains and managed care providers.
Safe Harbor: This news release contains forward-looking statements madepursuant to the safe-harbor provisions of the Private Securities LitigationReform Act of 1995. Such statements are based on management's currentexpectations and are subject to risks and uncertainties that could causeactual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in theCorporation's filings with the Securities and Exchange Commission, includingItem 1A to the Corporation's annual report on Form 10-K, and include, but arenot limited to: information of a preliminary nature that may be subject toadjustment, potentially not obtaining or delay in obtaining FDA approval fornew products, governmental restrictions on the sale of certain products,development by competitors of new or superior products or less expensiveproducts or new technology for the production of products, the entry into themarket of new competitors, market and customer acceptance and demand for newpharmaceutical products, availability of raw materials, timing and success ofproduct development and launches, dependence on few products generatingmajority of sales, product liability claims for which the Company may beinadequately insured, and other risks identified in this report and from timeto time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. Wedisclaim, however, any intent or obligation to update our forward-lookingstatements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.