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The FDA flagged the facility for environmental monitoring and a facility investigation, as well as a deviation and calibration out of tolerance discrepancy. Read More
The FDA rapped six device facilities for a variety of deficiencies identified during inspections, including problems with CAPAs and medical device reporting. Read More
China’s National Medical Products Administration is increasing its scrutiny of foreign manufacturers and will begin routine, risk-based inspections of foreign facilities to confirm they are in compliance with Chinese regulations. Read More
Some of the firm’s device history records didn’t document that the devices were manufactured with the correct parts or correct number of parts. Read More