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."
Thursday, December 16, 2010
FDA Uncovers More Problems At J&J Fort Washington Plant
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