FDA Finds Multiple Quality Violations At Synthes Plant

Law360, New York (March 6, 2012, 1:39 PM EST) -- The U.S. Food and Drug Administration said Tuesday it discovered several violations at a Synthes Inc. manufacturing facility in Pennsylvania, and sent a warning letter saying applications for devices related to the problems will not be approved until changes are made.

The letter, issued on Feb. 16 but posted to the agency’s website on Tuesday, said the Synthes plant in West Chester, Pa., which makes screws used in spinal surgeries, is not conforming to current federal government good manufacturing practice requirements and the company did not...
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