UPDATE 1-US warns Synthes on device violations, threatens fine

Tue Mar 6, 2012 11:45am EST

By Anna Yukhananov

March 6 (Reuters) - U.S. regulators warned Swiss medical device maker Synthes Inc about violations at its plant in Pennsylvania, and said the company may have to pay a fine if it fails to fix the problems.

Synthes, which is in the process of being bought by Johnson & Johnson, did not have a good way of monitoring and investigating complaints about its devices, the Food and Drug Administration said in a warning letter posted online on Tuesday.

Synthes' manufacturing issues come after Johnson & Johnson had its own series of high-profile product recalls and quality control problems with products such as infant Tylenol and artificial hips.

In the letter dated Feb. 16, the agency said Synthes failed to report serious complaints about its devices to the FDA within 30 days, as required by law.

"Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice," Kirk Sooter, director of the FDA's Philadelphia district office, wrote in the letter.

"We will co-operate and work diligently with the FDA until these deficiencies are fully resolved," Synthes spokesman Gilgian Eisner said in an email. J&J referred comments or questions to Synthes.

Synthes makes artificial spinal disc implants and other products used in spine surgery, as well as plates, screws and rods used to repair the bones of trauma patients. The company generated sales of $4 billion last year.

J&J agreed to buy Synthes for $23.1 billion, its largest-ever acquisition, but must first gain approval from antitrust regulators.

The FDA found the Synthes violations during an inspection of its plant in West Chester, Pennsylvania, carried out June 22 through Sept 15 of last year. The FDA said Synthes responded to its initial complaints on Sept. 29 but the agency did not have evidence that the company had corrected the problems.

The full FDA letter can be found here:.

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