It turns out that the recent seizure by the FDA of a million parts and medical devices from the Union, NJ manufacturing plant of Shelhigh, Inc. was not the first regulatory action concerning sterility problems taken in recent years by the FDA against Shelhigh. Shelhigh sterility violations resulted in FDA warning letters being issued in 2000 and again in 2005. During the recent raid on the plant, the FDA found that Shelhigh’s “clean room” where sterile devices are further prepared was poorly maintained and non-sterile.
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