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FDA Issues Follow Up Warning Letter to ReGen Biologics

By Staff(AXcess News) Franklyn Lakes NJ - The Food and Drug Administration (FDA) issued a follow-up warning letter to ReGen Biologics, Inc(OTCBB: RGBI) on Friday.

ReGen, an orthopedic products company, said it would respond to the FDA's follow-up warning letter through its response to the FDA's Form 483 notice of inspectional observations.ReGen stated in a news release that it disclosed to shareholders its receiving the FDA warning letter in its second quarter 2005 10-Q.The company filed its second quarter 10-Q on August 11, 2005. Sales were negligable as were research and development expenditures during that period.

Gerald E. Bisbee, Jr., Ph.D.

, ReGen's CEO, was quoted as saying,"ReGen is firmly committed to obtaining pre-market approval of the CMI and to being in compliance with all procedures and regulations as we do so. In its response to the Form 483 and in separate communications with the FDA, ReGen has responded to the issues identified in the warning letter. Corrective actions have been initiated to address the observations made by the FDA and at this point in time most of the items have been completed. The company will continue to work diligently with the FDA to ensure that proper corrective actions are implemented to ensure the highest level of regulatory compliance.

"Shares of ReGen closed Friday at $0.83, unchanged, onslight trading volume of only 7,900 shares.
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