Siemens Healthcare Diagnostics, part of Siemens (NYSE:SI), has received a warning letter from the U.S. Food and Drug Administration over allegedly changing without following proper protocol the design of an immunoassay device used to test blood and other biological liquids.
The letter, addressed to its Tarrytown, New York office dated May 29, said the company violated good manufacturing practices over changes made to its AD VIA Centaur iPTH immunoassay. The regulator faulted the company on alleged procedural violations to ensure the design fit the requirements for the device’s intended use. The company was missing documents to demonstrate that formal documented reviews of the design were being conducted at the appropriate stages.
Although Siemens’ premarket notification review was made in September 2009, followed by a regulatory assessment and then a validation report nine months later, the letter said the changes made to the device were not reflected in the paperwork.
“The effect of the device changes on performance was not documented until these reports were completed, but your firm’s assessment claims that there was no change in performance requiring a premarket submission,” the letter said.
The regulator also took the device manufacturer to task over what it said was its failure to adequately review and evaluate complaints over the device to determine whether an investigation was necessary.
The letter warned that the FDA could take regulatory action if it did not receive a response from Siemens addressing the points raised in the letter.
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