Phrase: "Despite an incident report from late last year," "Almost a year after it was first seen," and similar phrases
From: Warning letter 320-11-002 to CP Pharmaceticals
CP, mentioned earlier in this report for receiving a warning containing the phrase "Because responses were received more than 15 business days after the Form FDA 483 was issued," makes the list a second time for the same letter. The regulator writes, "An incident report, initiated in November 2009, identifies holes in the ceiling and visible light coming from the roof near the ventilation system, bubbling of the vinyl and disintegration of the wall under vinyl in the freeze dryer room...."
CP is by no means the only drugmaker to receive a letter indicating the FDA's awareness that a problem has persisted or remains unaddressed. The regulator's message: time is up.