Dade Behring cited in FDA warning letter for delays in correcting problems with IVD preservatives.
This article was originally published in The Gray Sheet
Executive Summary
DADE BEHRING DELAYS IN CORRECTING PROBLEMS WITH PRESERVATIVES is alleged by FDA in a Nov. 25 warning letter to the company. Following an Oct. 14-17 inspection of the firm's Cupertino and San Jose, California facilities, FDA found that problems identified as "critical, safety or regulatory in nature" did not receive quick corrective action.