WASHINGTON (Reuters) - U.S. inspectors are still uncovering a host of problems at a Johnson & Johnson manufacturing plant that was the source of a major recall of dozens of popular children’s medications earlier this year.
In an inspection report released late on Wednesday, the Food and Drug Administration said a recent visit uncovered multiple quality control problems, including a failure to properly handle customer complaints.
Inspectors also found “a failure to thoroughly review any unexplained discrepancy” in batches of products and a lack of proper record keeping, according to the report from an inspection that ran from October 27 to December 9.
The plant in Fort Washington, Pennsylvania, has been closed since April.
The FDA is reviewing the inspectors’ findings, FDA spokesman Christopher Kelly said. “The agency is not currently in a position to make conclusions regarding their significance,” he said.
In a statement, J&J’s McNeil Consumer Healthcare unit said it had been “working diligently to ensure that our manufacturing operations meet the level of quality that consumers and the FDA expect of us.”
“While the company has made progress toward that goal, this is an ongoing commitment and we will invest all necessary resources in order to achieve it,” McNeil said.
McNeil has recalled a string of products, and the quality control problems have drawn attention from U.S. authorities and Congress, hurt sales and tarnished J&J’s reputation.
Last week, the company recalled Softchews Rolaids antacids after consumers reported finding wood and metal bits in the tablets. Other recalls have involved children’s Tylenol, heartburn medicine Mylanta and other products.
The FDA also has cited problems at a J&J plant in Puerto Rico.
Investigations and the recalls themselves have grabbed investor attention as sales take a hit and executives depart. In October, J&J said sales of its consumer products fell 25 percent.
Earlier on Wednesday, the company announced leadership changes that include new oversight of its consumer group at the chairman’s office.
FDA released the latest inspection report on its website at http:/link.reuters.com/qyb42r.
Johnson & Johnson shares closed down 0.3 percent at $62.57 on the New York Stock Exchange.
Reporting by Susan Heavey and Lisa Richwine; Editing by Tim Dobbyn, Phil Berlowitz
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