'Unjustifiably delayed and terminated prematurely'

Phrase: "Unjustifiably delayed and terminated prematurely"
From: Warning letter SJN-2010-01, to McNeil Consumer Healthcare

In this mid-January warning letter, the FDA notes that Johnson & Johnson's McNeil group had received "numerous" complaints over four months before taking action to determine the cause of the musty-smelling Tylenol and related products. Then, when testing disproved the company's theory of microbial contamination as the cause, it closed the investigation.

"No other possible root causes were pursued," the letter says. "Your investigation into the root cause of the odor was unjustifiably delayed and terminated prematurely. Your firm lacked adequate justification for this decision."

The final FDA count cited in the warning also concerns timeliness: In violation of code, McNeil filed no NDA-Field Alert Reports within the required three days of its notification of the contamination.


'Unjustifiably delayed and terminated prematurely'