To: Gullapalli who wrote (1249 ) 8/3/1999 9:36:00 PM From: Charlie Smith Respond to of 1754
Gullapalli: Here's why. All the stocks in LVC group were hit today.Summit Warned About Sterility Problems With Eye Surgery Device Waltham, Massachusetts, Aug. 3 (Bloomberg) -- Summit Technology Inc., which makes equipment for vision correction surgery, didn't ensure the tiny steel blades used in the company's microkeratome vision correction system were properly sterilized, the U.S. Food and Drug Administration warned. The warning letter followed a May inspection of Summit's facility in Cork, Ireland, and said that the company had no sterilization specifications for the blades. The lack of sterilization standards raised such concerns about the company's ability to guarantee the sterility of the blades that the FDA said it may halt product imports until Summit corrects the problems. The lack of documentation ''raises concerns as to whether the microkeratome blades distributed by your firm were adequately sterilized,'' the letter said. The letter was dated July 14, 1999 and was released today through the FDA's Freedom of Information office. The company didn't return calls seeking comment. Summit's microkeratomes are manufactured by an unnamed third party in Germany, according to company filing with the Securities and Exchange Commission. Those products are then tested by Summit's Ireland plant. The inspection also found that the sealed packaging of the blades had never been tested, according to the letter. Summit shares fell 1 15/16 to 21 3/16 in late trading. The FDA sends hundreds of warning letters to companies each year, and only a small minority result in any significant agency action. However, the letters can be the last notice before the FDA takes steps such as delaying approvals of new products or pursuing civil fines. Aug/03/1999 15:47