KATECHO, INC. PACKAGE LIFE STUDIES WILL BE COMPLETED BY FEB. 1
This article was originally published in The Gray Sheet
Executive Summary
KATECHO, INC. PACKAGE LIFE STUDIES WILL BE COMPLETED BY FEB. 1 on products the company makes for other medical device firms under their 510(k)s, the original equipment manufacturer said in a Jan. 12 letter to the agency. Responding to a Jan. 5 warning letter, which cites GMP deviations observed during a Dec. 3-13, 1993 inspection of the company's manufacturing operations, Katecho said it will also conduct performance studies on its customers' products. The plant inspection was generated by Katecho's filing of a 510(k) premarket notification.
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