FDA Warns Synthes, Inc. on Device Violations,Threatens Fine

Philadelphia Business Journal by John George, Senior Reporter

The Food and Drug Administration issued a warning letter to Synthes USA citing its West Chester U.S. headquarters “failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints” about its spinal implant products and devices.

The letter was dated Feb. 16 and posted on the agency’s Web site on Tuesday.

In its letter, the FDA states Synthes’ failure to “promptly correct” these violations may result in the company being subjected to civil money penalties or other regulatory action by the FDA without further notice.

Snythes is in the process of being bought by Johnson & Johnson (NYSE:JNJ) for $19 billion.