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Biotech / Medical : Gliatech (GLIA)
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To: Dr. John M. de Castro who wrote (1691)8/17/2000 6:08:01 PM
From: Dr. John M. de Castro  Read Replies (2) of 2001
 
GLIA Inspection. This is from the merger proxy statement. Does anyone know what a Form 483 is and how serious this may be?

"In early 2000, the FDA inspected Gliatech's Ohio facilities and issued to Gliatech a Form 483 report containing specific observations by the FDA inspectors. In March 2000, Gliatech responded to the observations in the Form 483. Gliatech has not received further information from the FDA regarding the status of the agency's review of Gliatech's responses, except that the FDA informed Gliatech that the responses were under review. Actions the FDA may take could include the issuance of a formal warning letter or other enforcement action. These actions could have a material adverse effect on Gliatech and the combined company after the merger."
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