FDAnews Device Daily Bulletin

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 or cleared. According to the May 29 warning letter, the AD VIA Centaur iPTH immunoassay is adulterated and misbranded because Siemens never notified the FDA of its intent to sell the product prior to putting it on the market. The letter stems from an Oct. 24, 2011, to Dec. 29, 2011, inspection by the agency’s New York District Office.
The GMP Letter