Biogenex Handed Form 483 Over Devices, Complaints
Device failures and inadequate complaint handling procedures resulted in a Form 483 for Biogenex Laboratories, a maker of automated molecular pathology workstations.
The July 1 form was issued after inspections at the company’s U.S. headquarters in Fremont, Calif.
According to the form, 10 of 15 complaints about the company’s 16000 and Matric automated cell and tissue staining devices that Biogenex reviewed indicated the firm didn’t investigate the problem. One complaint cited liquid sensing failures, resulting in failure to stain, while others involved ejection problems with pipet tips, components out of plumb and a nonworking latch.
Biogenex told the FDA that the 10 incidents weren’t investigated because of wear and tear beyond the expected life of the device or lack of proper system maintenance. The form also chides Biogenex for not documenting complaints upon receipt.
In addition, in 14 of the cases, the field service engineers receiving the complaints did not document the nature of the problem and the date it was received before support staff entered them into an electronic activity log.
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