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FDA warns J&J’s Synthes over manufacturing violations

The US Food and Drug Administration (FDA) has warned Swiss-based Synthes, the medical device manufacturer currently in the middle of a takeover from Johnson & Johnson (J&J), it could face a financial penalty if it doesn't fix problems at its Pennsylvania facility.

The good manufacturing practice (GMP) violations involved such devices as polyaxial heads and pedicle screws used as part of the company's Click'X 3-D system for posterior stablilsation of the lower back, as well as the dynamic N-Hance Rods for use in a person's spine.

The FDA said Synthes failed to establish and maintain procedures for "implementing corrective and preventive actions" involving a complaint about the functioning of the Click'X 3-D devices, with Synthes omitting several lots of Click'X 3-D heads from corrective actions.

Other infringements highlighted by the FDA include failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by and failing to properly inform the FDA of serious complaints in the set time period.

"Your firm did not provide evidence that its correction and corrective actions have been implemented," the FDA said in a warning letter regarding complaints about both Click'X 3-D Heads and N-Hance Rods.

In addition to this mishandling of complaint procedures, the FDA also commented that its inspection revealed Synthe's devices at Pennsylvania were misbranded in that the company "failed or refused to furnish material or information respecting the device".

Synthes is advised to "take prompt action to correct the violations addressed in this letter" with failure to comply potentially resulting in regulatory action from the FDA that could include seizure, injunction, and/or fines.

J&J agreed to purchase Synthes in April, 2011, in a deal worth $21.3bn – the biggest purchase in the company's history.

J&J itself is no stranger to unsatisfactory manufacturing practices and over the past two years has faced multiple recalls and quality control problems at its own Pennsylvania facility in Fort Washington.

The effects were felt in the company's 2011 financial results, with litigation charges of $2.86bn dragging net profit down by 89 per cent.

8th March 2012

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