Count another public-relations strike against Johnson & Johnson ($JNJ). A McNeil Consumer Healthcare plant in Puerto Rico--the one where several recently recalled drugs were made--hasn't fixed all the manufacturing violations identified by FDA inspectors in January, despite promises to the contrary, a new report indicates.
As the New York Times reports, agency inspections from September to November this year found that the Puerto Rico plant has several of the same problems it did when FDA inspectors last visited, at least eight months after the agency issued a warning letter to McNeil chief Peter Luther. "Clearly, this inspection shows that the company continues to have serious quality control issues at its plant and that it is not in compliance with current good manufacturing practices required by federal law," FDA spokeswoman Karen Riley told the Times.
McNeil says it has responded to the FDA's latest concerns and that it has been working hard to improve its manufacturing processes. But the continued violations in Puerto Rico come at a bad time, after repeated recalls have put the company in a quality-control spotlight--a highly public one, at that. Executives have repeatedly promised to fix J&J's quality woes, but the steady drumbeat of recalls has undermined those promises. Indeed, the company just last week recalled another 9 million bottles of Tylenol Cold Multi-Symptom products because of a labeling oversight.
Add in the apparent management snafus such as the "phantom recall" of Motrin tablets that raised eyebrows in Congress, and now this failure to fix ongoing manufacturing problems, and you have a recipe for doubt, not confidence.
- see the NYT piece
- read the Wall Street Journal article
- get more from Pharmalot