Siemens Healthcare Diagnostics has received its second FDA warning letter this summer, following an inspection of the company’s Newark, Del., plant. The new batch of charges stem from the company’s handling of flawed product. The latest letter, dated June 29, follows an inspection that stretched from Dec. 14, 2011, to Feb. 9, 2012, and generated a three-observation Form 483 for the company. The FDA sent a warning letter to a different Siemens plant in Tarrytown, N.Y., in May. That letter said the company was marketing an unapproved diagnostic.
Devices & Diagnostics Letter