26.05.2010

FDA: J&J Unit Needs More Inspection After Lapses

The U.S. Food and Drug Administration (FDA) is calling for further inspection and an outside audit of a Johnson & Johnson unit following manufacturing lapses. The FDA, in a warning letter made public on Tuesday, cited multiple problems at Advanced Sterilization Products, a division of J&J's Ethicon, including failures to verify design changes needed to make sure devices work properly. The division also did not ensure that finished devices met necessary requirements, among other violations, the FDA wrote March 12. more