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Tyson Bioresearch Lands 483 for Procedural Problems

July 27, 2017

Tyson Bioresearch landed a Form 483 from the FDA due to failure to establish adequate procedures for several operations.

A March inspection of Tyson’s Miaoli County, Taiwan, facility found the company failed to initiate corrective and preventive actions as required for deviations from its quality objectives in 2015 and 2016. Further, the firm had not validated a process used in production of its glucose test strips.

The firm’s handling of complaints also contravened its standard operating procedures. A review of several complaints related to the company’s blood glucose monitoring system found none contained documented evidence of an evaluation for medical device reporting.

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