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FDA finds more problems at J&J plant

A US Food and Drug Administration inspection report cites additional quality control problems at J&J's Fort Washington plant

In an inspection report released December 15, the US Food and Drug Administration (FDA) states that a recent visit to the Johnson & Johnson (J&J) manufacturing plant at Fort Washington, Pennsylvania has 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 based on an inspection that ran from October 27 to December 9.

The Fort Washington plant was the source of a major recall of dozens of popular children's medications earlier this year and has been closed since April.

According to a FDA spokesman, Christopher Kelly, the agency is reviewing the inspectors' findings, and is not currently in a position to make conclusions regarding their significance.

J&J's McNeil Consumer Healthcare unit has made a public statement in which it claims that it had been "working diligently to ensure its manufacturing operations meet the level of quality that consumers and the FDA expect”.

"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.

The FDA also has cited problems at a J&J plant in Puerto Rico.

Earlier on December 15, J&J announced leadership changes that include new oversight of its consumer group at the chairman's office.

16th December 2010

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