www.fdanews.com/articles/148075-warning-letter-states-siemens-marketed-unapproved-diagnostic
Warning Letter States Siemens Marketed Unapproved Diagnostic
July 20, 2012
Siemens Healthcare Diagnostics has come under FDA scrutiny after an inspection at its Tarrytown, N.Y., plant found the company was marketing a diagnostic test that had never been officially approved.
The GMP Letter
The GMP Letter