Tyco’s Respiratory Unit Receives Fourth FDA Warning Letter This Year
This article was originally published in The Gray Sheet
Executive Summary
Tyco Healthcare has received four warning letters from FDA citing quality systems deficiencies in its respiratory products division in the last eight months
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Tyco Healthcare: Firm plans to invest $15 mil.-$20 mil. to step up its regulatory and quality affairs programs, according to President Rich Meelia. During Tyco's earnings call Feb. 2, Meelia reported that the healthcare division has separated its quality assurance from regulatory affairs in an effort to "aggressively resolve" compliance issues plaguing the imaging and respiratory segments, which resulted in the receipt of four warning letters directed at the company in 2005 (1"The Gray Sheet" Oct. 10, 2005, p. 9). "We feel very confident in our fixes. The relationship and the interaction we've been having with the FDA has been extremely positive," Meelia said, noting that one warning letter already has been resolved. Regulatory issues reduced first quarter sales by $26 mil.; however, the firm expects sales growth to be back in the mid-single-digit range in the second half of 2006...
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