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Biotech / Medical : Closure Medical (CLSR) fomerly Tri-Point Medical (TPMC)
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To: Phil Bennett who wrote (49)10/7/1997 4:56:00 PM
From: Joe Btfsplk   of 184
 
FDA Issues Warning Letter To Closure Medical About 2 Pdts

RALEIGH, N.C. -- Closure Medical Corp. (CLSR) received a warning letter from the Food and Drug Administration alleging the company responded inadequately to complaints about its Octyldent dental adhesive.

In the letter dated Sept. 10, the FDA alleged Closure didn't establish and implement an adequate system for handling complaints. Some complaints remained outstanding for several months, the FDA said, according to Federal Filings Business News. Closure said it got the letter Sept. 15 and responded Sept. 30, and added that a re-inspection should be scheduled "as soon as possible."

In a written statement, Closure said it believes the issues, related to Octyldent and its Nexacryl veterinary topical adhesive but not to its Dermabond product, can be "resolved soon." Closure said it is revising customer complaint handling, investigation and reporting procedures and that an "agressive" vendor audit program will be complete by the end of the month.

Closure Medical said the letter, which was a follow-up to an earlier inspection, raised no safety or efficacy concerns and sought no delay in the shipping of any products. The company said it expects to shortly complete required validations, most of which involve more detailed record keeping.
George
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