J&J plant report heightens QC questions

During the congressional hearings about Johnson & Johnson's (NYSE: J&J) huge children's drug recall back in June, FDA Deputy Commissioner Joshua Sharfstein cited a "pattern of noncompliance" at McNeil Consumer Healthcare that caused the agency to step up its inspections of company plants. As details emerge about the most recent McNeil plant to be chastened by the FDA--a manufacturing facility in Lancaster, Pa., owned by a joint venture with Merck--Sharfstein's "pattern" appears to grow stronger.

Just as employees at the now-shuttered Fort Washington, Pa., plant failed to follow up on consumer complaints about children's drugs, McNeil workers in Lancaster failed to investigate complaints that different flavors--and even different strengths--of Pepcid tablets were mixed up in product bottles, the FDA says. The Lancaster plant also failed to check the quality of Mylanta products turned out after equipment failed during manufacturing, inspectors say.

What's more, FDA investigators complained they had to ask repeatedly for records and waited days for those documents, even though the records are required to be readily accessible, the Wall Street Journal reports.

The inspection report is more evidence that McNeil's quality control efforts aren't up to speed, analysts say. "How do you get mint [flavored Pepcid] into berry if you're controlling your manufacturing process?" Jan Wald, an analyst with Noble Financial Capital Markets, tells Reuters. Not to mention the price of addressing the problems; Wald predicted the Lancaster fixes could be costly, and Morningstar analyst Damien Conover tells the news service that there's "a remote chance" the facility could be shut down. But, as Wald points out, the Lancaster issues are less serious than those in Fort Washington.

- check out the WSJ piece
- get more from Reuters